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Dr Mohan Z Mani

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Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : December | Volume : 16 | Issue : 12 | Page : SC06 - SC09 Full Version

Efficacy of Maternal Magnesium Sulfate Administration on the Neurodevelopmental Outcome of Preterm Babies: A Randomised Controlled Trial


Published: December 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/57435.17333
Lakshmi Mohanan Sheeba, Aparna Namboodiripad, Manoj C Varanattu

1. Senior Resident, Department of Paediatrics, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India. 2. Associate Professor, Department of Paediatrics, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India. 3. Professor and Head, Department of Neonatology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.

Correspondence Address :
Dr. Aparna Namboodiripad,
Associate Professor, Department of Paediatrics, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
E-mail: apnarel@gmail.com

Abstract

Introduction: Cerebral Palsy (CP) is a disability which shows an increased incidence with prematurity and Low Birth Weight (LBW). Many studies suggest that Magnesium Sulfate (MgSO4) given to mothers expected to deliver preterm improves their neurodevelopmental outcome.

Aim: To assess the role of administration of MgSO4 in improving neurodevelopmental outcome in preterm babies.

Materials and Methods: This was a hospital-based, prospective interventional study open label, randomised controlled trial conducted from December 2015 to May 2016 in the Department of Neonatology at Jubilee Mission Medical College in Central Kerala, India. Randomisation was done in deliveries expected to occur at or below 34 weeks. The mothers were then divided into two groups, those who would receive either MgSO4 or a placebo (normal saline). A total of 83 babies were compared for their baseline characteristics, and the association of MgSO4 administration on neonatal mortality, and on Amiel-Tison angle abnormalities and developmental delay at six months was studied. Either Chi-square test or Fisher’s exact test was used to compare the percentages. Microsoft excel was used to enter data. IBM Statistical Package for the Social Science (SPSS) version 21.0 was used for analysis. Statistical significance was considered for p-value <0.05.

Results: Both groups were comparable on baseline characteristics. MgSO4 use in mothers was not significantly associated with reduction in neonatal mortality (p-value=0.205). At six months of age, use of MgSO4 was associated with significant reduction in Amiel-Tison angle abnormalities (p-value <0.001), and reduction in developmental delay as assessed by Trivandrum Development Screening Chart (TDSC) (p-value <0.001), showing that MgSO4 has a neuroprotective role.

Conclusion: Although the percentage of neonatal deaths in the MgSO4 group were less, it was not statistically significant. Amiel-Tison angle abnormalities were significantly less in the group which received MgSO4. Neurodevelopmental outcome as assessed by TDSC was also significantly less in the group which received MgSO4. This suggests that antenatal MgSO4 protects preterm babies from cerebral palsy and neurodevelopmental disabilities. A larger study with a longer follow-up is suggested to confirm these findings.

Keywords

Amiel-Tison angle abnormalities, Cerebral palsy, Developmental delay, Newborns trivandrum development screening chart

Cerebral palsy (CP) is a disability with enormous emotional and financial costs and its incidence increases with prematurity and LBW (1). Many trials and meta-analyses suggest that giving MgSO4 in the antenatal period has a favourable effect on the neurodevelopmental outcome of premature babies (2),(3),(4),(5). Excitatory stimuli are down-regulated by MgSO4 and this is postulated to reduce nerve damage. MgSO4 blocks N-methyl-D-Aspartate (NMDA) receptors and hence, reduces injury caused to the brain by glutamate. MgSO4 also reduces calcium entering the cell and thus neuronal death (6). Damage to preterm brain was reduced when MgSO4 was given when proinflammatory cytokines were used to induce inflammation (7). Another mechanism by which magnesium is thought to reduce damage to neurons is by reducing apoptosis (8). Transplacental transfer of magnesium occurs within an hour of maternal intravenous administration (9).

The MgSO4 is commonly used in the antenatal period for severe pre-eclampsia and for tocolysis (3). Several studies have suggested that MgSO4 given antenatally for pre-eclampsia or tocolysis is associated with a reduction in CP in Very Low Birth Weight (VLBW) and preterm babies and in deaths in the perinatal period (10),(11),(12),(13),(14),(15). This benefit by MgSO4 given in the antenatal period is not seen however in all studies on the risk of Intraventricular Haemorrhage (IVH), CP or perinatal mortality (16),(17),(18),(19),(20).

A Cochrane systematic review that studied MgSO4 administration to mothers expected to deliver prematurely concluded that there is a need for evaluation of motor function of these babies later in childhood (21). Another systematic review of studies evaluated the latest evidence regarding use of MgSO4 to prevent neuronal injury when given to mothers expected to deliver prematurely and concluded that more studies are needed to formulate the most accurate regimens for protection of the preterm brain (22).

Although several developed countries have formulated guidelines for antenatal administration of MgSO4 for neuroprotection, only a few Indian studies, and still less from Kerala have been conducted to assess the efficacy of the same in our population (23),(24),(25),(26),(27),(28).

The authors studied the effect of two separate interventions (umbilical cord milking and MgSO4 given to mothers expected to deliver prematurely) on the outcome of preterm babies with regard to their neurodevelopment. The data on the effect of milking of the cord on neurodevelopmental outcome at 6 months of age has already been published (29). The present study aimed to identify whether preterm babies whose mothers received MgSO4 had a better survival at discharge, and neurodevelopmental outcome at six months of age, when compared to those whose mothers did not.

Material and Methods

This was a hospital-based, prospective interventional study open label, randomised controlled trial that was conducted from December 2015 to May 2016 in the Department of Neonatology at Jubilee Mission Medical College in Central Kerala, India. The study was conducted after obtaining clearance from Institutional Ethical Committee (reference no. 03/15/IEC/IMMC and RI).

Inclusion and Exclusion criteria: Expectant mothers who were of the gestational age of 24-34 weeks were recruited into the study if birth was expected within 24 hours. Foetuses with severe malformations such as neural tube defects, and chromosomal abnormalities like trisomies, that would interfere with assessment of tone and developmental milestones were excluded, as were cases of maternal hypotension, renal insufficiency, hepatic insufficiency, and cardiac rhythm or electrolyte abnormalities.

The gestational age was calculated during recruitment to the study using the date of the last menstrual period and the results of the earliest available ultrasonogram.

Study Procedure

Eligible participants who gave consent were assigned randomly using sealed envelope method. The premature neonates who were born were then divided into two groups on the basis of their mothers receiving MgSO4 or the placebo (Table/Fig 1).

Group 1 (n=40): Mothers who received MgSO4 as a 4 g intravenous bolus initially. Then an infusion of 1 g/hr was given for 24 hr or until birth, whichever came first.
Group 2 (n=43): Mothers who was given a placebo infusion of normal saline.

The intervention was not concealed from the patients. The infusion was stopped if delivery did not take place within 24 hours.

Sample size calculation: Based on the proportion of neurodevelopmental delay observed in an earlier publication by Nelson KB and Grether JK, that investigated whether antenatal MgSO4 had an association with a lower prevalence of CP in newborns who had a weight of less than 1500 g, among the 42 VLBW infants who developed CP, only 7.1% had received MgSO4 in the antenatal period when compared 36% of the 75 controls with 95% confidence level and 90% power, the minimum sample size came to 40 in each group (30).

The formula used and the calculation done are as follows:


n=[1.96* v({2*0.215*0.785})+1.28* v{0.07*0.93+0.36*0.36}]^2/(0.07-0.36)^2
n=40

Total of 45 babies were selected for each group. However, two babies in group 1 who were born to women not exposed to antenatal MgSO4, and five babies in group 2 who were born to women exposed to MgSO4 were lost for follow-up. Hence, 43 infants in group 1 and 40 infants in group 2 were included in the study. The 83 infants thus selected were then followed-up from birth upto six months.

Parameters Assessed

1) Birth weight: This were assessed in two ways i) those who were above 1500 g are Very Low Birth Weight (VLBW) (31) and ii) those below 1500 g.

2) Gestational age: This was recorded in two ways i) those above 32 weeks of gestational age, and ii) those below 32 weeks.

3) Baseline characteristics: The babies in the two groups were also compared regarding gender, Premature Rupture of Membranes (PROM), previous abortions, Gestational Diabetes Mellitus (GDM), pregnancy induced hypertension (PIH), and infections like neonatal sepsis. Data was collected from hospital records and physical examination of babies.

4) Number of neonatal deaths: Primary outcome was measured by comparing the number of neonatal deaths in the two groups.

5) Amiel-Tison angles (32),(33): It was used for detecting abnormalities of tone at six months of corrected gestational age for all the babies enrolled in the study.

6) Trivandrum Development Screening Chart (TDSC) (34): TDSC was used to detect developmental delay. There are 17 test items in the validated tool called TDSC. Lines are drawn vertically at the corrected chronological ages of babies. If the baby has not achieved the developmental milestones that are on the left of the line, then that baby is diagnosed to have delay in development.

Statistical Analysis

Microsoft excel was used to enter data. Data was expressed as percentages and frequencies. Either the Chi-square test or the Fisher’s exact test was used to compare the percentages. IBM SPSS Statistics for Windows version 21.0 was used for statistical analysis. Statistical significance was considered for p-value <0.05.

Results

In the present study, most babies had a gestational age of 32-34 weeks. There was one baby less than 28 weeks gestational age in each of the 2 groups (who received and did not receive MgSO4). The babies in each group were divided into those below 32 weeks and above, and the difference between the two groups was not significant (Pearson’s Chi-square test, p-value=0.50).

In this study, most babies were in the VLBW group. The number of babies below 1500 g and above 1500 g in each group was comparable, and the difference between the two groups was not significant (Pearson’s Chi-square test, p-value=0.670).

There were more male children in the group who did not receive MgSO4 and more female children in the group who received MgSO4. However this was not statistically significant (Pearson’s Chi-square test, p-value=0.225).

Mothers in both groups were comparable with regard to the incidence of PROM, PIH, previous abortions, and GDM, and the incidence of infections like neonatal sepsis (Table/Fig 2).

The percentage of neonatal deaths in the MgSO4 group was 2.5% when compared to 9.3% in those who did not receive MgSO4. However, this was not statistically significant (p-value 0.361, Fisher’s exact Test) (Table/Fig 3).

At six months corrected gestational age, 25/43 (58.1%) of those who had not received MgSO4 had Amiel-Tison angle abnormalities when compared to 9/40 (22.5%) of those who received MgSO4. This was statistically significant (p-value <0.001) (Table/Fig 4).

At six months corrected gestational age, on neurodevelopmental evaluation of all surviving infants using TDSC, 23/43 (53.5%) of those who did not receive MgSO4 had developmental delay as assessed by TDSC when compared to 3/40 (7.5%) of those who received MgSO4. This was statistically significant (p-value <0.001) (Table/Fig 5).

Discussion

The present study was conducted to identify whether preterm babies whose mothers received MgSO4 had a better neonatal survival and neurodevelopmental outcome at six months of age, when compared to those whose mothers did not. The two groups were comparable regarding gestational age. This is important as extreme prematurity is an added risk factor for the presence for neurodevelopmental delay (1),(2).

In the present study, neonatal deaths in the MgSO4 group was 2.5% when compared to 9.3% in those whose mothers did not receive MgSO4. However, this was not of statistical significance (p-value=0.361). Bansal V and Desai A, also concluded that antenatal magnesium sulfate given to women in established preterm labour was not associated with increase in neonatal deaths. There were 5 (10%) neonatal deaths amongst the 50 whose mothers received antenatal MgSO4 while there were only 2 (4%) deaths in the neonates whose mothers did not receive MgSO4 and the results were not significantly associated with MgSO4 (p-value=0.436) (27). A Cochrane review in 2009 by Doyle LW et al., examining the impact of MgSO4 on CP in five trials had also concluded that MgSO4 given to expectant mothers did not significantly alter the incidence of neonatal deaths (RR 1.04; 95% CI 0.92-1.17; 5 trials, 6145 infants) (21). A 2019 systematic review and meta-analysis of 197 studies by Shepherd E et al., found no clear difference for perinatal deaths in randomised trials between those given MgSO4 and those who were not (RR 1.01; 95% CI 0.92 to 1.10; 8 trials, 13,654 babies) (35).

Abnormalities in Amiel -Tison angles were found in 58.1% of those who had not received MgSO4 while it was found in 22.5 % of those who did. This was statistically significant (p-value=0.001). In a study in Mysore by Prakash R et al., MgSO4 was given for neuroprotection in the postnatal period for babies with birth asphyxia. Amiel-Tison assessment did not reveal much difference in tone abnormality (out of 22 infants in the group given MgSO4, 3 had abnormal Amiel-Tison angles while abnormalities wer only found in 4 out of the 19 who were not given MgSO4 In this study the relative risk was 0.65; 95% CI, 0.16-2.54; p-value=0.53.

At six months corrected gestational age, 53.5% of those who did not receive MgSO4 had developmental delay as assessed by TDSC when compared to 7.5% of those who received MgSO4. This was statistically significant (Chi-square test, p-value <0.001). A previous study by Prakash R et al., on babies with birth asphyxia given postnatal MgSO4, developmental delay measured by TDSC at 12 months of age did not show a statistically significant difference. The incidence of delay in development was found in three infants who were given MgSO4 out of a total of 22 while five infants were found to have delay amongst the 19 infants who were not given MgSO4 (relative risk, 0.51; 95% CI,0.14-1.88; p-value=0.32) (36). Cochrane review in 2009 by Doyle L et al., (21) concluded that there was a decrease in CP when MgSO4 was given (RR 0.68; 95% CI 0.54-0.87). There were four trials where MgSO4 was given specifically for protecting the brain, and these too showed a significant reduction in CP. (RR 0.71; 95% CI 0.55-0.91). There was a decrease in both CP (RR 0.64; 95% CI 0.44-0.92) as well as a dysfunction of the gross motor functions (RR 0.61; 95% CI 0.44-0.85).

The present study had assessed babies for tone using Amiel-Tison angles and developmental delay using TDSC at six months of age. This may be too early an age for diagnosis of cerebral palsy, as postulated by Kato T et al., who in their study of the popliteal angle found that babies weighing less than 2 kg had higher tone of the legs when they were four months of age (37). The authors concluded that this may hence be too early an age for diagnosis of spastic CP. They concluded that the popliteal angle is a much better predictor of CP in babies with periventricular leukomalacia at one year of age.

Antenatal MgSO4 is a relatively inexpensive treatment. This study adds to the body of evidence supporting the role of MgSO4 in reducing the incidence of cerebral palsy in preterm infants and emphasises the need for large multicentric trials in India.

Limitation(s)

The sample size was relatively small. The follow-up for neurodevelopmental outcome was only for six months. The significance of our findings maybe validated by larger, blinded, multicentric studies with a longer follow-up.

Conclusion

Although the percentage of neonatal deaths in the MgSO4 group were less, it was not statistically significant. Amiel-Tison angle abnormalities were significantly less in the group which received MgSO4. Neurodevelopmental outcome as assessed by TDSC was also significantly less in the group which received MgSO4.

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DOI and Others

DOI: 10.7860/JCDR/2022/57435.17333

Date of Submission: May 05, 2022
Date of Peer Review: Jul 20, 2022
Date of Acceptance: Sep 12, 2022
Date of Publishing: Dec 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. No

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: May 10, 2022
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• iThenticate Software: Sep 08, 2022 (10%)

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