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...
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The Korean Pediatric Society
2025-01-01
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Series: | Clinical and Experimental Pediatrics |
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Online Access: | http://www.e-cep.org/upload/pdf/cep-2024-00591.pdf |
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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. |
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id | doaj-art-3351dc0c38a34edabb9a841d9fb072a8 |
institution | Kabale University |
issn | 2713-4148 |
language | English |
publishDate | 2025-01-01 |
publisher | The Korean Pediatric Society |
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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 |
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