Short-Term Outcomes of Early Oral Colostrum Administration in VLBW Neonates: An Open-Label Randomized Controlled
Sedigheh Tehranchi1, Farzaneh Palizban1, Maryam Khoshnood Shariati1
1Clinical Research Development Center, Mahdiyeh Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Early oral colostrum priming (OCP) in very low birth weight (VLBW) neonates was found to be safe but did not improve short-term outcomes. This study indicates OCP does not significantly impact infection rates, feeding milestones, or overall mortality in VLBW infants.
Area of Science:
- Neonatal Medicine
- Pediatric Nutrition
- Clinical Trials
Background:
- Oropharyngeal colostrum priming (OCP) is a proposed nutritional intervention for very low birth weight (VLBW) neonates.
- Early administration of colostrum via the oral route is being explored for potential benefits in this vulnerable population.
Purpose of the Study:
- To evaluate the short-term clinical outcomes associated with early oral colostrum administration in VLBW neonates.
- To determine if OCP impacts key neonatal morbidities and growth parameters.
Main Methods:
- An open-label randomized controlled trial involving VLBW neonates.
- Participants were randomized to receive oral colostrum (intervention) or no oral colostrum (control).
- Statistical analyses included t-tests, chi-square, and Fisher exact tests to compare outcomes between groups.
Main Results:
- No significant differences were observed between the OCP group and the control group regarding PICC infections, sepsis, NEC, IVH, ROP, or BPD.
- Time to reach 120 cc/kg feeds, time to regain birth weight, length of hospitalization, and mortality rates showed no significant variations between the groups.
- A total of 76 VLBW neonates (37 intervention, 39 control) were included in the final analysis.
Conclusions:
- Early oral colostrum administration is safe for VLBW neonates.
- OCP did not demonstrate significant improvements in the evaluated short-term outcomes for VLBW infants.
- Further research may be needed to explore potential long-term effects or alternative OCP protocols.
Background:
Oropharyngeal colostrum priming (OCP) has been proposed as a potential nutritional option for very low birth weight (VLBW) newborns. This study aimed to determine short-term outcomes of early oral colostrum administration in VLBW neonates.
Methods:
This open-label randomized controlled trial was conducted on VLBW neonates admitted to Mahdieh Hospital, Tehran, Iran, between February and December 2022. According to the protocol, all eligible neonates were randomized evenly to the intervention group, which received oral colostrum (OC), and the control group, which received no OC. Finally, short-term outcomes of early OC administration were compared between groups using the independent-samples t test, chi-square, and Fisher exact tests.
Results:
Of 80 randomized neonates, 37 and 39 from the intervention and control groups entered the final analysis, respectively. Neonates in the intervention and control groups did not significantly differ in terms of peripherally inserted central catheter (PICC) infection (P = 0.728), sepsis (P = 0.904), necrotizing enterocolitis (NEC) (P > 0.999), intraventricular hemorrhage (IVH) (P = 0.141), retinopathy of prematurity (ROP) (P = 0.923), and bronchopulmonary dysplasia (BPD) (P = 0.633). Furthermore, there was no significant difference between groups considering the time to reach 120 cc/kg feeds (P = 0.557), time to reach birth weight (P = 0.157), length of hospitalization (P = 0.532), and mortality rate (P = 0.628).
Conclusion:
The results of our study revealed that despite safety, early OC administration did not improve any of the short-term outcomes in VLBW neonates.
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