Hemodynamic Effects of Umbilical Cord Milking versus Early Cord Clamping in Non-vigorous Intrauterine Growth Restricted Neonates: A Randomized Controlled Trial

Aim: To evaluate the effects of umbilical cord milking (UCM) compared to early cord clamping (ECC) on hemodynamic parameters in intrauterine growth restricted neonates requiring resuscitation.

Population: Antenatally detected IUGR neonates > 28-weeks gestation who are non-vigorus (defined as per NRP AAP) at birth.

IUGR - Defined as fetal weight in serial ultrasonography below the 10th percentile for the gestation as per INTERGROWTH 21st standard.

Intervention: NICU and delivery unit team would be trained in the study procedure before the trial is started. In all cases after birth, the neonates will be placed on the mother’s abdomen in case of vaginal delivery and on the thighs in case of Caesarean delivery before clamping the cord. The intervention in the UCM group will include gentle grasping of the uncut umbilical cord and squeezing approximately 20 cm of the cord at the speed of 10cm/sec towards the infant for four times. A short waiting time of 2 seconds in between two squeezing movements will be ensured for quick refilling the cord.

In ECC group, the delivering obstetrician will place the baby on the mother as previously described and clamp the umbilical cord within 30 seconds and attending Neonatologist will transfer the neonate under radiant warmer. Neonatal care would be provided according to standard practice at the hospital.

Sample size: In a study comparing UCM with ECC in non-vigorous late preterm and term neonates, mean ± SD left ventricular output was 225 ± 64 vs 187± 52 mL/kg/min, respectively. Expecting a similar difference in primary outcome, considering power of the study as 80% and 2 tailed alpha error as 0.05, a total sample size of 74 was calculated (37 in each group)

Statistical methods: All the data will be uploaded into the excel sheet (Microsoft excel 2016). IBM SPSS version 21.0 to be used for data analysis. Analysis of data will be done by using SPSS software version 21. Continuous variables with normal distribution will be presented as mean ± SD. Categorical variables will be presented as proportions. Quantitative data with normal distribution will be compared using Student T test and those with skewed distribution will be analyzed using Mann Whitney U test. Data expressed as proportions will be compared using Chi square or Fisher exact test as applicable. Mean and 95% confidence interval will be calculated for outcome variables. Subgroup analysis will be done as per stratifications with analysis of variance (ANOVA) test. A p-value of <0.05 will be considered statistically significant.