Trial reportInternational breastfeeding journal2021
Oropharyngeal administration of colostrum for preventing necrotizing enterocolitis and late-onset sepsis in preterm infants with gestational age ≤ 32 weeks: a pilot single-center randomized controlled trial.
Trial report in International breastfeeding journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 5 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Nutritional management of neonates who undergo major surgery for gastrointestinal disorders: a joint position paper of the Italian Society of Neonatology (SIN), the Italian Society of Pediatric Surgery (SICP), and the Italian Society of Pediatric Nutrition (SINUPE).Italian journal of pediatrics · 2026Guideline
- [Effect of colostrum oral immune therapy on the the clinical outcomes in very low birth weight infants: a Meta analysis].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025Pooled it
- Quality improvement interventions to prevent neonatal necrotizing enterocolitis: a systematic review.Frontiers in pediatrics · 2025Pooled it
- Effect of Breast Milk Oral Care on Mechanically Ventilated Preterm Infants: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in pediatrics · 2022Pooled it
- Intervention Effect of Oropharyngeal Administration of Colostrum in Preterm Infants: A Meta-Analysis.Frontiers in pediatrics · 2022Pooled it
- Investigating the effect of oropharyngeal colostrum in the prevention of late-onset sepsis in preterm infants: a randomized controlled trial.Scientific reports · 2025Trial
- A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants.Journal of perinatology : official journal of the California Perinatal Association · 2023Trial
- Oropharyngeal colostrum administration in neonates with gastroschisis: a randomized clinical trial.Critical care scienceTrial
- Definitions of neonatal Necrotizing Enterocolitis (NEC) in randomised controlled trials: a systematic review.Journal of perinatology : official journal of the California Perinatal Association · 2026Review
- A Prospective-Retrospective Observational Cohort Study of Short-Term Health Outcomes of Preterm Very Low Birth Weight Infants Receiving Oropharyngeal Administration of Own Mother's Colostrum.Current therapeutic research, clinical and experimental · 2026Article
- Developing and implementing a family-led infection prevention bundle for hospitalized neonates.Antimicrobial resistance and infection control · 2026Article
- The microbiome's hidden influence: preclinical insights into inflammatory responses in necrotizing enterocolitis.Seminars in immunopathology · 2025Review
- Clinical Applications of Bovine Colostrum in GastrointestinaI Disorders: Mechanisms, Evidence, and Therapeutic Potential.International journal of molecular sciences · 2025Review
- Impact of colostrum oropharyngeal immunotherapy on postnatal growth in preterm infants based on early gut microbiota-host interaction patterns: protocol for a randomized controlled trial.International breastfeeding journal · 2025Article
- Article
- Optimizing breastfeeding for hospitalized newborns: A narrative review of midwifery-led interventions.European journal of midwifery · 2025Review
- Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial.Clinical and experimental pediatrics · 2025Article
- Influence of oropharyngeal therapy with mother's own milk on the microbiome and metabolome of very preterm infants: a pilot study.Frontiers in nutrition · 2025Article
- Intestinal metabolomics in premature infants with late-onset sepsis.Scientific reports · 2024Article
- Antisecretory factor in breastmilk is associated with reduced incidence of sepsis in preterm infants.Pediatric research · 2024Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOropharyngeal administration of colostrum (OAC) may provide immunoprotective and anti-inflammatory effects that potentially reduce the incidence of necrotizing enterocolitis (NEC) and late-onset sepsis and improve short-term outcomes. Our objective was to evaluate the role of OAC in the early prevention of NEC and late-onset sepsis in preterm infants with gestational age (GA) ≤ 32 weeks.
methodsA pilot, single-center, 1:1 parallel randomized controlled trial was conducted in a 40-bed tertiary neonatal intensive care unit (NICU) in China from 1 January 2019 to 30 September 2020. Preterm infants were randomly divided into two groups with GA ≤ 32 weeks. The OAC group included preterm infants who received 0.4 ml of maternal colostrum via the oropharyngeal route every 3 h for 10 days beginning within the first 48 h after birth, and the control group included preterm infants who received normal saline instead. Data from the two groups were collected and compared.
resultsA total of 127 infants in the OAC group and 125 infants in the control group were enrolled. The incidence of NEC (Bell stage 2 or 3) and late-onset sepsis were lower in the OAC group [2.36% vs. 10.40%, relative risk (RR) 0.23 (95% confidence interval (CI) 0.07, 0.78), adjusted RR 0.23 (95% CI 0.06, 0.84); 4.72% vs. 13.60%, RR 0.35 (95% CI 0.14, 0.85), adjusted RR 0.36 (95% CI 0.14, 0.95)]. In addition, the incidence of proven sepsis and intraventricular hemorrhage (IVH) (stage 3 or 4) were lower in the OAC group [2.36% vs. 8.80%, RR 0.27 (95% CI 0.08, 0.94); 1.57% vs. 7.20%, RR 0.22 (95% CI 0.05, 0.99)], and the time to achieve full enteral feeding was shorter (23.13 ± 9.45 days vs. 28.50 ± 14.80 days). No adverse reactions were observed in either group.
conclusionsOropharyngeal administration of colostrum is a safe and simple NICU procedure that may yield a potential effect in decreasing the incidences of NEC, late-onset sepsis, and severe IVH and shorten the time to achieve full enteral feeding in preterm infants with GA ≤ 32 weeks.
trial registrationChinese Clinical Trial Registry, ChiCTR1900023697 , Registered 8 June 2019, retrospectively registered.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.