Health Condition 1: P072- Extreme immaturity of newborn Health Condition 2: P070- Extremely low birth weight newborn Health Condition 3: P071- Other low birth weight newborn Health Condition 4: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Intervention: Immediate initiation of KMC within 2 hours of birth or admission (depending upon whether the baby is inborn or outborn) for all preterm and low birth weight infants requir
Sponsors
World Health Organization
Dr Vishwajeet Kumar
Eligibility
Inclusion criteria
Inclusion criteria: Preterm (gestational age <37 weeks) or low birth weight ( <2.5 kg at birth) requiring care in the SNCU, i.e., who are <1800 grams or gestational age <34 weeks (SNCU admission criteria), or those preterm or LBW newborns who are above these cut-offs but are sick and need SNCU admission.
Exclusion criteria
Exclusion criteria: Preterm or LBW newborns requiring SNCU care who are critically sick, example: - Are unable to breathe spontaneously within the first hour after birth or have congenital malformations that interfere with the intervention, or the intervention interferes with the required care for the congenital malformation (e.g., anencephaly, congenital heart disease, gastroschisis, hydrocephaly, multiple malformations, omphalocele, tracheoesophageal fistula, abdominal detention. etc.) -Are in shock (in need of inotropes) or -Are receiving invasive mechanical ventilation in the first 2 hours of birth or admission to SNCU; or -Liveborn who died in the first 2 hours of birth or first 2 hours of admission or were dead at the time of admission to the iKMC implementing facility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome for Phase I: Model Development An optimized implementation model that achieves a high coverage & quality of iKMC & establishes the norm of zero separation between the mother & her newborn Proportion of preterm or LBW newborns (henceforth referred to as small newborns) requiring care in level 2 SNCUs either born in or brought to the iKMC implementing facility within 24 hours of birth (denominator), who received iKMC defined as initiation of KMC within the first 2 hours of birth (for inborn infants) or first 2 hours of admission (for outborn infants) & received at least 8 hours per day of skin-to-skin contact on average during their stay in the facility. Primary outcome for Phase 2: Model evaluation Proportion of preterm or LBW infants who died during the first 28 days of life (neonatal mortality rate among the trial participants).Timepoint: Phase 1- 18 Months Phase 2- 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Quality Outcomes: Proportion of preterm or LBW infants who arrived to an iKMC implementing facility within 24 hours after birth among those born in a health facility who required referral at birth to an iKMC implementing facility Proportion of preterm or LBW infants on respiratory support (any oxygen or CPAP) who received skin-to-skin contact 8 hours/day in the M-SNCU Proportion of preterm or LBW infants receiving KMC at discharge (8-24 hours of skin-to-skin contact & exclusively breastfed) in the 24 hours before discharge from the iKMC implementing facility Proportion of preterm or LBW infants who are exclusively breastfed at discharge Median age at putting the baby to the breast for the first-time during M-SNCU stay Implementation Outcomes: a)Acceptability b)Adoption c)Adaptation d)Cost e)FidelityTimepoint: End of every month during phase I (for implementation quality improvement), & at end of Phase I (approx. 18 months, for outcome evaluation);Phase 2 Breastfeeding: · Proportion of preterm or LBW infants who are exclusively breastfed at discharge from trial facilities. ·Median age at putting the baby to the breast for the first-time during M-SNCU/SNCU stay. ·Median age at initiation of breastmilk feeding during the M-SNCU/SNCU stay â?¢ Proportion of preterm or LBW infants with clinical sepsis â?¢ Proportion of preterm or LBW infants who has hypoglycaemia: Any blood glucose level of 45 mg per decilitre, measured when clinically indicated during M-SNCU/SNCU stay, as per the SNCU protocol of each study â?¢ Proportion of preterm or LBW infants who has hypothermia: Any axillary temperature 36°C during M-SNCU/SNCU stay â?¢ Proportion of preterm or LBW infants receiving KMC at discharge (8-24 hours of skin-to-skin contact & exclusively breastfed in the 24 hours before discharge) from the trial facilityTimepoint: End of every week during Phase 2 (for implemenmtation quality improvement), & at end of Phase 2 (approx. 24 months, for outcome | — |
Countries
India
Contacts
Public ContactAarti Kumar
Community Empowerment Lab
Outcome results
None listed