Reviewer’s comments
Manuscript title: Delayed vs Early Umbilical Cord Clamping in 100 Preterm Infants: an RCT from Bhavnagar, Gujarat.
I complement the authors for conducting this study on an extremely important and low-cost intervention aimed at improving preterm short- and long-term outcomes. However, the following points require consideration by the authors.
Title of the paper
- Why is it relevant to cite the place of work in the Title of the paper? The title should incorporate the PICO and the type of study i.e., an RCT. The setting of the study i.e., urban tertiary care hospital can be mentioned. The authors must look at the CONSORT guidelines for reporting an RCT.
Introduction
- The sentence ‘Even small effects on each individual may have a great impact when multiplied in a large population’ is not necessary in the introduction.
- Was permission obtained for reproducing Fig 1 and Fig 2?
- It would be better to cite the author by the surname. For example, instead of Vikram [3] reported significantly better short-term…, it would be better to write Datta et al reported ….. .
Aim and Objectives
- The Primary Objective stated does not match with the objective mentioned in the Abstract.
Material & methods
- Was the trial registered with CTRI?
- The outcome variables being studied for SAFETY, FEASIBILITY and EFFICACY as mentioned in the Objective of the study in the abstract is to be described.
- What outcome variable of interest has been used to calculate the sample size?
- The fact the neonates were stable preterm neonates and not requiring intensive care or NICU admission requires to be mentioned.
- Were the deliveries attended by a doctor or supervised by a doctor who was part of the study team? If not, then contribution of the midwives or nurses needs to be acknowledged.
- Case definitions followed are required to be mentioned. What guidelines were used for decision for phototherapy? How much blood was taken for CBC and how was it done – manual or coulter?
- More information about the setting of the study needs to be provided.
Table 1
- The 1 min APGAR score must be mentioned as a median (IQR). 1 min APGAR of 47 in DCC and 45 in ECC has no meaning. What about the 1 min APGAR? Do the authors want to state Normal 1 min APGAR?
- Antenatal steroid coverage rate in the maternal population requires to be mentioned in Table 1.
Table 2
- What proportion of neonates required NICU admission? Number of babies with RDS is very small to be able to identify a significant difference. Similarly, the babies have mean gestational age of 32 weeks which puts them at less risk for IVH.
Discussion
- The authors must use the Cochrane review on Delayed cord clamping updated in 2019 in their discussion.
- The discussion must bring out why the study was unable to identify any significant difference in preterm morbidities, because now there is significant body of evidence that DCC provides respiratory and hemodynamic stability. Studies by Dipak et al (Indian Pediatrics) and Tewari et al (J Tropical Pediatrics) show these benefits.
- Salient differences in the study population from those in published literature maybe highlighted to identify the possible reasons for not being able to identify a significant benefit of DCC in preterm morbidities.
- The proportion of babies developing jaundice is exceptionally low in both the arms. What guidelines were followed for deciding on management of jaundice in the study population?
General comment
- I encourage the authors to write the manuscript keeping in mind he CONSORT guidelines and also seek help for improving the grammar and sentence framing in the manuscript.
- I wish them all the best.
Comments
Thank you very much for the detailed review. I will try to incorporate it.