NCT06447155

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Istanbul Training and Research Hospital · Other Government
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Not accepted

Summary

Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH. The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.

Detailed description

Objectives: The investigators aimed to evaluate the clinical consequences of different types of enteral nutrition during TH in babies with HIE. Methods: This single-center, prospective randomized controlled trial (RCT) was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital. A cohort of 60 infants with HIE, born at 35 0/7 to 42 6/7 weeks of gestation who received TH were enrolled. The infants enterally fed with bolus feeding during hypothermia (n =20), those who were fed continuously (n=20) constituted the study groups. The control group (n =20) was composed of neonates who were not fed. Infants were monitored for clinical consequences such as feeding intolerance, time to full enteral feeding, duration of hospitalization, necrotizing enterocolitis and mortality.

Conditions

• Hypoxic Ischemic Encephalopathy of Newborn
• Feeding Patterns

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bolus feeding	The babies fed with bolus feeding during TH composed this group
DIETARY_SUPPLEMENT	Continuous feeding	The babies fed with continuous feeding during TH composed this group
DIETARY_SUPPLEMENT	Placebo	The babies who were not fed during TH composed this group

Timeline

• Start date: 2024-06-15
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: Turkey (Türkiye)