Related Experiment Video
Updated: Mar 19, 2026
Breast Milk Enhances Growth of Enteroids: An Ex Vivo Model of Cell Proliferation
Published on: February 15, 2018
Role of melatonin for prevention of necrotizing enterocolitis in preterm infants: a randomized controlled trial
Hebatallah A Shaaban1, Hisham A Awad1, Ola G El-Farghali1
1Pediatric Department, Faculty of Medicine, Ain Shams University, Cairo, P.O. Box 11381, Egypt.
Insights
Enteral melatonin significantly reduced necrotizing enterocolitis (NEC) incidence and mortality in preterm infants with feeding intolerance. This therapy also accelerated feeding and lowered inflammatory markers, offering a promising, accessible treatment option.
Area of Science:
- Neonatal Medicine
- Gastroenterology
- Pharmacology
Background:
- Feeding intolerance (FI) in preterm infants is a critical concern, often linked to necrotizing enterocolitis (NEC).
- Oxidative stress (OS) is a key factor in neonatal diseases, including NEC.
- Melatonin shows potential in reducing OS and related neonatal conditions.
Purpose of the Study:
- To evaluate the efficacy of enteral melatonin in managing FI symptoms in preterm neonates.
- To compare the incidence of NEC, mortality rates, and tumor necrosis factor-alpha (TNF-α) levels between melatonin and conventional therapy groups.
- To assess the impact of melatonin on the time to achieve full enteral feeding.
Main Methods:
- Ninety preterm neonates with FI were randomized into two groups: melatonin (MT) plus conventional therapy (CT) and CT alone.
- Melatonin was administered enterally at 10 mg twice, one hour apart.
- TNF-α levels were measured 72 hours post-treatment.
Main Results:
- The melatonin group showed significantly lower NEC incidence, mortality, and TNF-α levels compared to the CT group.
- Preterm infants receiving melatonin achieved full enteral feeding faster and had shorter hospital stays.
- Conventional therapy was associated with extended hospital stays, delayed feeding, and higher NEC rates.
Conclusions:
- Enteral melatonin is an effective and safe treatment for preterm infants with feeding intolerance, reducing NEC incidence and mortality.
- Melatonin therapy accelerates enteral feeding, lowers inflammatory markers, and is a practical, affordable option for low-resource settings.
- This study supports melatonin as a valuable therapeutic agent in neonatal care, particularly for preventing and managing NEC in preterm infants.
Abstract:
Feeding intolerance (FI) in preterm infants may signal necrotizing enterocolitis (NEC), in which oxidative stress (OS) plays a central role. Melatonin has demonstrated promise in mitigating neonatal OS-related diseases. The study is aimed to assess the effect of enteral melatonin on the progression of FI symptoms, NEC incidence, and tumor necrosis factor-alpha (TNF-α) levels in preterm neonates with FI, compared with conventional therapy (CT). Ninety preterm neonates with FI were randomly assigned to either the melatonin group (MT, n = 45), who received melatonin plus conventional therapy, or the conventional group (CT, n = 45), who received conventional treatment. Melatonin was administered enterally in two doses of 10 mg each, 1 h apart. TNF-α levels were measured in all patients 72 h posttreatment. CT group experienced extended hospital stay, longer feeding discontinuation, delayed full enteral intake, higher NEC incidence, increased mortality, and higher TNF-α compared with the MT group (P = .032, <.001, <.001, <.001, .03, and <.001, respectively). Enteral melatonin significantly reduced NEC incidence and mortality, accelerated achievement of full enteral feeding, and lowered TNF-α levels in preterm neonates with FI. It demonstrates a practical, affordable, orally administered therapy that is accessible and reproducible in low-resource settings, addressing the burden of NEC in preterm infants where it is critically needed.
