Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy

NCT06394453 | Recruiting

• 1 other identifier: NutriciaFoundation
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day, 30 ml/kg/day during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.

Conditions

Newborn Asphyxia

Keywords

therapeutic hypothermia, hypoxic-ischaemic encephalopathy

Outcome Measures

Primary Outcomes (2)

• Combined Necrotizing enterocolitis or death

  Necrotizing enterocolitis will be defined by the modified Bell's staging criteria (stage II or stage III)

  from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, during hospital stay, an average of 8 weeks

• Length of hospital stay

  assessed from day of birth until discharge from hospital, an average of 8 weeks

Secondary Outcomes (8)

• Time to full enteral feeding

  assessed from day of birth until discharge from hospital, an average of 8 weeks

• Late-onset sepsis

  assessed from day of birth until discharge from hospital, an average of 8 weeks

• Test of Infant Motor Performance scoring

  assessed from day of birth until discharge from hospital, an average of 8 weeks

• MRI scoring

  assessed until the end of the third month of life

• MR spectroscopy parameter

  assessed until the end of the third month of life

Study Arms (2)

control group

NO INTERVENTION

Control group will be unfed orally during 72 hours of therapeutic hypothermia. The group will be receiving parenteral nutrition (PN) from day one onwards. Parenteral nutrition will be defined as receiving any type of nutrient solution in any volume through any route of administration (peripheral venous cannula, central venous catheter, or umbilical catheter).

experimental group

EXPERIMENTAL

Experimental group will start receiving enteral feeding at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day and 30 ml/kg/day during third day. Additionally will be receiving parenteral nutrition (PN) from day one onwards. Parenteral nutrition will be defined as receiving any type of nutrient solution in any volume through any route of administration (peripheral venous cannula, central venous catheter, or umbilical catheter). As the volume of enteral feeding will be increased, the volume of PN will be decreased gradually.

Other: enteral feeding with mother milk or human donor breast milk

Interventions

enteral feeding with mother milk or human donor breast milk OTHER

The experimental group will start enteral feeding with mother milk or human donor breast milk if mother milk is not accesible during the first day of therapeutic hypothermia.

experimental group

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks or more gestational age
• \< 6 hours post birth
• Any of the following:
• Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour after birth
• minute Apgar score of ≤5
• Ongoing resuscitation initiated at birth and continued for ≥10 minutes
• Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7
• Signed informed consent by parent

You may not qualify if:

• Critical general condition
• Aneuploidies (13 th , 18 th , 21 st )
• Birth weight \<1800 g
• Severe congenital defects with poor prognosis
• Severe mechanical head injuries
• Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)

Sponsors & Collaborators

• Nutricia Foundation: lead

Study Sites (1)

University Children's Hospital of Cracow, Neonatal intensive care unit

Krakow, 30-663, Poland

RECRUITING

MeSH Terms

Conditions

Asphyxia Neonatorum; Hypoxia-Ischemia, Brain

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Viktoryia Parfenchyk, MD

  Collegium Medicum Jagiellonian University in Cracow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoryia Parfenchyk, MD

CONTACT

+48 535275959; viktoryia.parfenchyk@uj.edu.pl

Matuesz Jagla, MD

CONTACT

mateusz.jagla@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physician

Model Details: All eligible newborns will be randomized to one of the two groups : 1. unfed during 72 hours of TH (control group); 2. fed group, which will start receiving enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day and 30 ml/kg/day during third day (experimental group).

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 1, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)