Infant death, enrolment to 28 days

Whether the baby died in its first 28 days of life.

Outcome
In this atlas

Overview

Technical summary

Mortality from enrolment to 28 days of age (the neonatal period), ascertained in hospital and by a home visit on day 29.

Definition

Infant death from enrolment to 28 days of age

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.

Primary 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.
In the iKMC trial, babies weighing 1.0 to under 1.8 kg at birth who started continuous skin-to-skin care with their mother within hours of birth were less likely to die in their first 28 days than babies who started it only after they were stable. 191 of 1596 babies died in the immediate group and 249 of 1587 in the control group (adjusted risk ratio 0.75, 95% CI 0.64 to 0.89).
Limitations. 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). The per-arm denominators (1596 and 1587) are smaller than the numbers randomized (1609 and 1602). They come from the author manuscript's Table 3 only, its text does not state their basis, and they were not checked against the version of record.

Record details

Record id: maternal:outcome-death-enrolment-to-28d
Content hash: 05be391ecc478a7004de1b19a631a4218e346d2e0b6ffc83350775ca840c028d