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The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE

NCT06344286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-03

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:

1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

DIETARY_SUPPLEMENT

Minimal enteral nutrition

The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements.

DIETARY_SUPPLEMENT

Distilled water

The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements.

Sponsors & Collaborators

  • Istanbul Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • DİDEM ARMAN · Istanbul Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-08-31
Completion
2022-10-31

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT06344286 on ClinicalTrials.gov