Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

June 3, 2024 updated by: DİDEM ARMAN, Istanbul Training and Research Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • IstanbulTRH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit >-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat & Sarnat classification based on neurological examination were treated with TH.

Exclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The babies fed with bolus feeding during TH
The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
Dietary supplement: Bolus feeding
The babies fed with bolus feeding during TH composed this group
Active Comparator: The babies fed with continuous feeding during TH
The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
Dietary supplement: Continuous feeding
The babies fed with continuous feeding during TH composed this group
Placebo Comparator: The babies who were not fed
The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
Dietary supplement: Placebo
The babies who were not fed during TH composed this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Necrotizing enterocolitis (NEC)
Time Frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
The infants will be monitorized for NEC development
From admission to NICU till postnatal 15th day or hospital discharge whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding intolerance
Time Frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
The infants will be monitorized for feeding intolerance
From admission to NICU till postnatal 15th day or hospital discharge whichever came first
Time to full enteral feeding
Time Frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
The infants will be monitorized for feeding intolerance
From admission to NICU till postnatal 15th day or hospital discharge whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulTRH-DArman-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data sets generated during and/or analyzed during current study may be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding Patterns

Clinical Trials on Bolus feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe