Brain injury from lack of oxygen around birth (HIE)

Brain injury in a newborn after a period of low oxygen around birth. Babies with moderate or severe HIE are the babies in the cooling trials recorded here.

Also called Hypoxic-ischemic encephalopathy · HIE · Neonatal encephalopathy

Condition
In this atlas

Overview

Technical summary

Studied with whole-body cooling in two trials whose results differ by setting: a trial in US neonatal units (published 2005) and HELIX in India, Sri Lanka and Bangladesh (published 2021). This record gives no clinical definition; the entry criteria of each trial are in the context records for its claims.

Recognition

Not defined here. Each trial's entry criteria are in its context record.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Treated by: Cooling treatment (therapeutic hypothermia) for HIE (Claimed to treat, seen from the other side)
Applies to Newborn
- Infants of at least 36 weeks of gestation admitted at or before 6 hours of age with severe acidosis, or perinatal complications and resuscitation at birth, who had moderate or severe encephalopathy. Of 239 eligible infants, 102 were assigned to cooling and 106 to usual care.
- Hospitals of the NICHD Neonatal Research Network. The abstract says admitted to the hospital; ClinicalTrials.gov lists sites in the United States.
- United States (ClinicalTrials.gov)
- Term and near-term newborns of at least 36 weeks, treated within the first 6 hours of life
- Gestational age at least 36 weeks 0 days, measured at birth
- Postnatal age Not reported
Follow-up Neurodevelopmental outcome was assessed at 18 to 22 months of age.
In the 2005 NICHD trial in infants of at least 36 weeks with moderate or severe encephalopathy, whole-body cooling to 33.5 degrees C for 72 hours lowered the combined outcome of death or moderate or severe disability at 18 to 22 months: 45 of 102 infants (44%) with cooling against 64 of 103 (62%) with usual care (risk ratio 0.72, 95% CI 0.54 to 0.95; P=0.01). Deaths alone were 24% against 37% (risk ratio 0.68, 95% CI 0.44 to 1.05; P=0.08), which was not statistically significant. The authors reported no increase in major disability among survivors.
Limitations. Randomised comparison with usual care. The result applies to this population and setting. The same treatment was tested in India, Sri Lanka and Bangladesh in the HELIX trial, which found no reduction in death or disability and more deaths with cooling. The ClinicalTrials.gov record describes cooling for 96 hours and the paper 72 hours; both are kept. Only the abstract was read.
Claim, not a settled fact Evaluated for this: Cooling treatment (therapeutic hypothermia) for HIE (Evaluated for, seen from the other side)
Applies to Newborn
- Infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 minutes of age or an Apgar score under 6 at 5 minutes (hospital births), or no crying by 5 minutes (home births). 408 infants were recruited: 202 to cooling and 206 to usual care.
- Seven tertiary neonatal intensive care units with facilities for invasive ventilation, cardiovascular support and 3 Tesla MRI.
- India, Sri Lanka and Bangladesh
- Term and near-term newborns, randomised within 6 hours of birth
- Gestational age at least 36 weeks 0 days, measured at birth
- Postnatal age Not reported
Follow-up The primary outcome was death or moderate or severe disability at 18 to 22 months.
In the HELIX trial in India, Sri Lanka and Bangladesh, whole-body cooling to 33.5 degrees C for 72 hours did not reduce the combined outcome of death or moderate or severe disability at 18 to 22 months: 98 infants (50%) with cooling and 94 (47%) with usual care (risk ratio 1.06, 95% CI 0.87 to 1.30; p=0.55). The authors concluded that cooling did not reduce the combined outcome in low-income and middle-income countries.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. Open-label trial in seven tertiary neonatal intensive care units; masking was not possible, though outcome assessors were masked. Primary outcome data were available for 195 of 202 infants in the cooling group and 199 of 206 in the control group. The result applies to this population and setting, and the NICHD trial in US units found a benefit, so the setting decides which claim applies. PubMed links a published correction (PMID 34450042, Lancet Global Health 2021, PMC8636277): it adds the list of HELIX consortium members to the article's appendix, and the correction notice describes no other change.
Claim, not a settled fact Evaluated for this: Cooling treatment (therapeutic hypothermia) for HIE (Evaluated for, seen from the other side)
Applies to Newborn
- Infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 minutes of age or an Apgar score under 6 at 5 minutes (hospital births), or no crying by 5 minutes (home births). 408 infants were recruited: 202 to cooling and 206 to usual care.
- Seven tertiary neonatal intensive care units with facilities for invasive ventilation, cardiovascular support and 3 Tesla MRI.
- India, Sri Lanka and Bangladesh
- Term and near-term newborns, randomised within 6 hours of birth
- Gestational age at least 36 weeks 0 days, measured at birth
- Postnatal age Not reported
Follow-up The primary outcome was death or moderate or severe disability at 18 to 22 months.
In the HELIX trial more babies died with cooling than with usual care: 84 infants (42%) against 63 (31%; p=0.022), and 72 (36%) against 49 (24%; p=0.0087) during neonatal hospitalisation. The authors state that cooling significantly increased death alone and that it should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even where tertiary neonatal intensive care is available. Five serious adverse events were reported (three with cooling, two in the control group), and none were judged causally related to the intervention.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. Death was a secondary finding of an open-label trial of 408 infants; the abstract prints the death counts without the group sizes beside them. The result is for the three South Asian countries studied. This record reports the finding as the trial reported it and does not extend it to other settings. PubMed links a published correction (PMID 34450042, Lancet Global Health 2021, PMC8636277): it adds the list of HELIX consortium members to the article's appendix, and the correction notice describes no other change.

Record details

Record id: maternal:hypoxic-ischaemic-encephalopathy
Content hash: 92c37466d5ac8bad29424284899945f9a3843a1d9f64558ba8b6b5220a0e1b88