Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial

Background The oropharyngeal administration of colostrum (OAC) in neonates has several benefits. Purpose To investigate the short-term outcomes of OAC in preterm neonates. Methods We performed this 2-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021...

Full description

Saved in:
Bibliographic Details
Main Authors: Ameneh Lamsehchi, Maryam Shokouhi Solgi, Mohammad Kazem Sabzehei, Behnaz Basiri, Elahe Talebi Ghane, Kiana Kimiaei Asadi, Sina Azadnajafabad
Format: Article
Language:English
Published: The Korean Pediatric Society 2025-01-01
Series:Clinical and Experimental Pediatrics
Subjects:
Online Access:http://www.e-cep.org/upload/pdf/cep-2024-00591.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1825206615687561216
author Ameneh Lamsehchi
Maryam Shokouhi Solgi
Mohammad Kazem Sabzehei
Behnaz Basiri
Elahe Talebi Ghane
Kiana Kimiaei Asadi
Sina Azadnajafabad
author_facet Ameneh Lamsehchi
Maryam Shokouhi Solgi
Mohammad Kazem Sabzehei
Behnaz Basiri
Elahe Talebi Ghane
Kiana Kimiaei Asadi
Sina Azadnajafabad
author_sort Ameneh Lamsehchi
collection DOAJ
description Background The oropharyngeal administration of colostrum (OAC) in neonates has several benefits. Purpose To investigate the short-term outcomes of OAC in preterm neonates. Methods We performed this 2-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021–2023. The intervention and control arms received 0.2 mL of their mother’s colostrum or distilled water via oropharyngeal administration every 6 hours for 3 days starting from birth until 72 hours of age. The main study outcomes were neonatal death, the incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity (ROP), length of hospital stay, and period to full enteral feeding. A regression analysis was used to adjust for possible confounders. Results A total of 126 neonates (mean gestational age, 30.05 weeks) were randomized to the intervention and placebo groups (n=63 each) and had a mean±standard deviation weight of 1,247±193 g versus 1,156±215 g (P=0.013) and 1- and 5-min Apgar scores of 6.35 versus 5.38 (P=0.003) and 7.84 versus 7.13 (P=0.001), respectively. The mortality rate was 12.7% in the intervention group versus 14.3% in the placebo group (P=0.794). The necrotizing enterocolitis rate was significantly lower in the intervention versus placebo arm (11.1% vs. 28.6%, respectively, P=0.010), as was the clinically suspected sepsis rate (15.9% vs. 39.7%, respectively, P=0.004). The ROP and bronchopulmonary dysplasia rates did not differ significantly between groups after the adjustment for confounders. The mean length of hospital stay was shorter in the intervention group (26.1 days vs. 37.32 days, P=0.023). Moreover, the mean duration of antibiotic therapy and period to full feeding were significantly shorter in the intervention group. Conclusion OAC could effectively decrease the incidence of complications in preterm infants and facilitate earlier patient discharge.
format Article
id doaj-art-3351dc0c38a34edabb9a841d9fb072a8
institution Kabale University
issn 2713-4148
language English
publishDate 2025-01-01
publisher The Korean Pediatric Society
record_format Article
series Clinical and Experimental Pediatrics
spelling doaj-art-3351dc0c38a34edabb9a841d9fb072a82025-02-07T07:38:34ZengThe Korean Pediatric SocietyClinical and Experimental Pediatrics2713-41482025-01-01681737910.3345/cep.2024.0059120125555729Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trialAmeneh Lamsehchi0Maryam Shokouhi Solgi1Mohammad Kazem Sabzehei2Behnaz Basiri3Elahe Talebi Ghane4Kiana Kimiaei Asadi5Sina Azadnajafabad6 Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran Modeling of Noncommunicable Diseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran Hamadan University of Medical Sciences, Hamadan, Iran Children’s Medical Center, Tehran University of Medical Sciences, Tehran, IranBackground The oropharyngeal administration of colostrum (OAC) in neonates has several benefits. Purpose To investigate the short-term outcomes of OAC in preterm neonates. Methods We performed this 2-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021–2023. The intervention and control arms received 0.2 mL of their mother’s colostrum or distilled water via oropharyngeal administration every 6 hours for 3 days starting from birth until 72 hours of age. The main study outcomes were neonatal death, the incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity (ROP), length of hospital stay, and period to full enteral feeding. A regression analysis was used to adjust for possible confounders. Results A total of 126 neonates (mean gestational age, 30.05 weeks) were randomized to the intervention and placebo groups (n=63 each) and had a mean±standard deviation weight of 1,247±193 g versus 1,156±215 g (P=0.013) and 1- and 5-min Apgar scores of 6.35 versus 5.38 (P=0.003) and 7.84 versus 7.13 (P=0.001), respectively. The mortality rate was 12.7% in the intervention group versus 14.3% in the placebo group (P=0.794). The necrotizing enterocolitis rate was significantly lower in the intervention versus placebo arm (11.1% vs. 28.6%, respectively, P=0.010), as was the clinically suspected sepsis rate (15.9% vs. 39.7%, respectively, P=0.004). The ROP and bronchopulmonary dysplasia rates did not differ significantly between groups after the adjustment for confounders. The mean length of hospital stay was shorter in the intervention group (26.1 days vs. 37.32 days, P=0.023). Moreover, the mean duration of antibiotic therapy and period to full feeding were significantly shorter in the intervention group. Conclusion OAC could effectively decrease the incidence of complications in preterm infants and facilitate earlier patient discharge.http://www.e-cep.org/upload/pdf/cep-2024-00591.pdfcolostrumpretermnewbornrandomized controlled trialnecrotizing enterocolitis
spellingShingle Ameneh Lamsehchi
Maryam Shokouhi Solgi
Mohammad Kazem Sabzehei
Behnaz Basiri
Elahe Talebi Ghane
Kiana Kimiaei Asadi
Sina Azadnajafabad
Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
Clinical and Experimental Pediatrics
colostrum
preterm
newborn
randomized controlled trial
necrotizing enterocolitis
title Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
title_full Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
title_fullStr Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
title_full_unstemmed Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
title_short Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial
title_sort short term outcomes of oropharyngeal administration of colostrum in preterm neonates a double blind placebocontrolled randomized trial
topic colostrum
preterm
newborn
randomized controlled trial
necrotizing enterocolitis
url http://www.e-cep.org/upload/pdf/cep-2024-00591.pdf
work_keys_str_mv AT amenehlamsehchi shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT maryamshokouhisolgi shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT mohammadkazemsabzehei shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT behnazbasiri shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT elahetalebighane shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT kianakimiaeiasadi shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial
AT sinaazadnajafabad shorttermoutcomesoforopharyngealadministrationofcolostruminpretermneonatesadoubleblindplacebocontrolledrandomizedtrial