Objective Primary outcome was to compare neurodevelopmental outcome at two years in intracytoplasmic sperm injection (ICSI) conceived children versus matched controls. Secondary outcome was to determine incidence of major congenital malformations and study perinatal outcome. Design Prospective cohort study.Setting Tertiary care perinatal centre over a period of 13 months.
Although there was no significant trend in neonatal survival or composite morbidity over the decade, improved survival and morbidity were seen with increasing GA.
Background: Meconium retention is associated with feeding intolerance. Trials using glycerol and Gastrografin to expedite the evacuation of meconium have failed to generate clinically valid results for efficacy and safety. Objective: We assessed the feasibility of aggressive meconium evacuation with saline rectal washout (RW) in very-low-birth-weight infants to reduce the time it took them to reach full enteral feeds. Methods: We conducted an open-label, pilot, randomized controlled trial (RCT) (birth weight stratified, i.e., to 750-999 g and 1,000-1,500 g) of early aggressive meconium evacuation with twice-daily normal saline RW compared to conventional management with glycerin suppositories (GS), until full enteral feeds (110 mL/kg/day) were reached. Primary outcome was time to reach full enteral feeds. Safety, process, and secondary efficacy outcomes were also evaluated. Results: Sixty-one infants were randomized, 28 to RW and 33 to GS. The process and feasibility outcomes were met. RW was found to be safe; none of the RW-randomized infants developed necrotizing enterocolitis (≥ stage II) or complications secondary to RW. Evidence of efficacy was supported: in the 750-999 g stratum (n = 15), the median time to full enteral feeds was shorter with RW (11.0 days, 95% CI: 10.4-11.6) than with GS (15.6 days, 95% CI: 13.0-18.2) by a reduction of 4.6 days (p = 0.027). In the 1,000-1,500 g stratum (n = 46), there was no evidence of benefit: RW 10.2 days (95% CI 8.3-12.1) and GS 10.1 days (95% CI 9.3-10.9, p = 0.304). Conclusion: Our protocol was feasible and an adequately powered RCT is required to confirm the findings of this trial.
It is important to thoroughly investigate all cases of NIHF and identify its causes in order to provide appropriate antenatal and postnatal counselling. In our series, almost one-third of NIHF cases had no identified aetiology. The neonatal mortality rate was approximately 58%.
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