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.
35 weeks or more gestational age
< 6 hours post birth
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
10-minute Apgar score of ≤5
Critical general condition
Aneuploidies (13 th , 18 th , 21 st )
Birth weight <1800 g
Severe congenital defects with poor prognosis
Parallel
enteral feeding with mother milk or human donor breast milk
Other interventionThe 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.
Combined Necrotizing enterocolitis or death
Necrotizing enterocolitis will be defined by the modified Bell's staging criteria (stage II or stage III)
Length of hospital stay
Time to full enteral feeding
full enteral feeding defined as newborn infants receive all of their prescribed nutrition as milk feeds and do not receive any supplemental parenteral fluids or nutrition
Late-onset sepsis
defined as sepsis occurring at or after 72 hours of life
Test of Infant Motor Performance scoring
MRI scoring
Using MRI scoring system by Rutherford et al., classifying the severity of injury in the basal ganglia and thalami (BGT), cortex (CX), white matter (WM) (each on a scale of 0-3) and posterior limb of the internal capsule (PLIC) (scale 0-2), the higher number indicating more severe abnormality. Total injury score (TIS) will be the sum of these regional scores (scale of 0-11)
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