MedTrace Logo

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

NCT06447155 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-06

No results posted yet for this study

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.

Conditions

  • Hypoxic Ischemic Encephalopathy of Newborn
  • Feeding Patterns

Interventions

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

Sponsors & Collaborators

  • Istanbul Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2026-06-15
Completion
2026-06-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06447155 on ClinicalTrials.gov