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

NCT06344286 | Completed

• 1 other identifier: IstanbulTRH-DArman-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Therapeutic hypothermia; Minimal enteral nutrition; Mesenteric oxygenation; Mesenteric blood flow; Splanchnic oxygenation; Cerebrosplanchnic ratio

Outcome Measures

Primary Outcomes (2)

• Cerebral and mesenteric blood flow velocities and oxygenation

  Cerebral and mesenteric blood flow velocities with Doppler US

  (From postnatal first day until postnatal 4 th day)Doppler US of SMA and MCA performed before feeding (15-30 minutes before) and 60 minutes after feeding

• Cerebral and mesenteric rSO2 values

  Cerebral and mesenteric rSO2 values with NIRS

  (From postnatal first day until postnatal 4 th day) Recording of NIRS data was commenced 60minutes before the initiation of TH and was continued during the procedure till 24 hours after cessation of TH

Secondary Outcomes (3)

• Development of NEC

  From admission to NICU till postnatal 15th day or hospital discharge whichever came first,

• Feeding intolerance

  From admission to NICU till postnatal 15th day or hospital discharge whichever came first,

• Time to full enteral feeding

  From admission to NICU till postnatal 15th day or hospital discharge whichever came first,

Study Arms (2)

Infants receiving MEN

ACTIVE COMPARATOR

The babies fed with minimal enteral nutrition during TH constituted the study group

Dietary Supplement: Minimal enteral nutrition

Infants receiving placebo

PLACEBO COMPARATOR

The babies who were given distilled water during TH

Dietary Supplement: Distilled water

Interventions

Minimal enteral nutrition DIETARY_SUPPLEMENT

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.

Infants receiving MEN

Distilled water DIETARY_SUPPLEMENT

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.

Infants receiving placebo

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

IstanbulTRH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• DİDEM ARMAN

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: An enteral intake of breast milk with a volume of 10-20 mL/kg/day was defined as minimal enteral feeding. Minimal enteral feeding was initiated at postnatal 24 hours with breast milk via an orogastric tube. A total daily intake of 120 ml/kg/day was defined as full enteral feeding. 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.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 3, 2024
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

TU (1)