Hypothermia (iKMC definition)

Whether the baby's temperature dropped too low at any point in hospital.

Outcome
In this atlas

Overview

Technical summary

The trial's own definition. Other studies define hypothermia differently, so this outcome is kept separate from any general hypothermia outcome.

Definition

Any axillary temperature below 36 °C at any time from 2 hours after randomization until hospital discharge

Unit: infants

Measured in

Studies in this atlas that report this outcome, by the claim each finding supports. Each finding keeps its own population, denominator and time window on the study page.

Secondary endpoint WHO Immediate KMC Study (iKMC) See the findings
Applies to Newborn
- Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
- Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
- Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
- Neonatal period
- Gestational age Any, not restricted
- Postnatal age 0 days to 0 days
Follow-up From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.
Fewer babies in the immediate skin-to-skin group had a recorded low temperature (under 36 °C at the armpit) during their hospital stay: 90 of 1609 versus 133 of 1602 (adjusted risk ratio 0.65, 95% CI 0.51 to 0.83).
Limitations. Secondary outcome. Its confidence interval is not adjusted for multiplicity, and the authors say such intervals should not be used to infer definitive effects. Temperatures were measured in an open-label trial. The trial's hypothermia definition differs from other studies. One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3).

Record details

Record id: maternal:outcome-hypothermia-ikmc
Content hash: 6f3aec170ee93d999af5d05e569eb348d32f1b5e18d8b6eb76205ea48990d8da