neonatal hypothermia
Conditions
Interventions
EENC alone
NEWS HEAT care bundle and EENC
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Facility level inclusion criteria Facilities are eligible to participate in the trial if they are: A level 4, 5 and 6 facilities in Kenya (according to Kenyan government health system levels), with an on-site labour ward, maternity theatre and neonatal unit. Willing to be randomised to either the intervention or comparator group and agree to sign a commitment to this, prior to randomisation, once relevant approvals are in place. Individual Inclusion criteria Inborn preterm (born at <37 weeks’ gestation) and/or LBW (birthweight <2.5kg) babies born in the participating facilities are eligible for inclusion.
Exclusion criteria
Exclusion criteria: Facility level exclusion criteria Healthcare facility that provides level 1-3 care (according to Kenyan government health system levels). Healthcare facility that does not have an on-site labour ward, maternity theatre or newborn unit. Participating in another trial that is evaluating hypothermia in the labour ward at the same time as NEWS-HEAT. Individual exclusion criteria Babies born at <24 weeks gestation Babies who weigh <500g at birth Babies born with a lethal congenital anomaly (e.g. anencephaly, Trisomy 13, Trisomy 18) Babies born with no reasonable prospect of survival, according to the attending clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal hypothermia, defined as <36.5°c at the point of admission to the next point of care (i.e. neonatal unit, postnatal ward). | — |
Secondary
| Measure | Time frame |
|---|---|
| Temperature upon admission to next point of care ;Severe hypothermia (temperature 37.5°c) ;Neonatal hypoglycaemia on admission to the next point of care, defined as blood glucose <2.6 mmol/L. Only to be recorded if blood glucose level is measured routinely as part of clinical care. ;Early neonatal death;Duration of admission ;Exclusive breast feeding at discharge home ;Antibiotics for early onset neonatal infection ;Acceptability of the NEWS-HEAT care bundle from the perspective of health professionals and policy maker;Fidelity of the NEWS-HEAT intervention | — |
Countries
Kenya
Contacts
Public ContactNewsHeat Trial
Trial Manager
Outcome results
None listed