Disorders of newborn related to short gestation or low birth weight Pregnancy and Childbirth
Conditions
Interventions
Background
Immediate Kangaroo Mother Care (iKMC) is a simple, cost-effective innovation that involves holding the preterm or low birth weight infant in skin-to-skin contact with the mother or caregiv
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 0.00 and 27.00 days 2. All genders 3. Preterm (gestational age <37 weeks) or low birth weight (<2.5 kg at birth) requiring care in the SNCU, i.e., who are <1800 g 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: 1. Preterm or LBW newborns requiring SNCU care who are critically sick, for example: 1.1. 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.) 1.2. Are in shock (in need of inotropes) or 1.3. Are receiving invasive mechanical ventilation in the first 2 hours of birth or admission to SNCU; or 1.4. 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 and quality of iKMC and establishes the norm of zero separation between the mother and her newborn The 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 the initiation of iKMC within the first 2 hours of birth (for inborn infants) or first 2 hours of admission (for outborn infants) and 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 The proportion of preterm or LBW infants who died during the first 28 days of life (neonatal mortality rate among the trial participants). The baby will be followed-up just after 28 days (at home or hospital if admitted) to record their current status to record if any mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes for Phase 1 measured using patient medical records at one timepoint: Quality Outcomes: 1. The proportion of preterm or LBW infants who arrived at 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 2. The 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 3. The proportion of preterm or LBW infants receiving iKMC at discharge (8-24 hours of skin-to-skin contact and exclusively breastfed) in the 24 hours before discharge from the iKMC implementing facility 4. The proportion of preterm or LBW infants who are exclusively breastfed at discharge 5. Median age at putting the baby to the breast for the first time during M-SNCU stay Implementation Outcomes will be captured from the hospital records of M-SNCU (Mother-Special Newborn Care Unit) to study case report forms at one timepoint: 1. Acceptability: iKMC including transport in skin-to-skin contact from the birthing place to M-SNCU is acceptable to mothers (and/or surrogates). Mothers and caregivers are satisfied with the care received. iKMC is acceptable to health workers (facility and community). Adoption: The challenges in the adoption of iKMC by mothers, hospital managers and health providers (nurses, midwives, doctors) identified in programme learning are addressed. 2. Adaptation: Modifications to adapt the iKMC intervention to the social and routine health system context are implemented. 3. Cost: what are the costs of implementing iKMC in routine healthcare settings? 4. Fidelity: Quality iKMC care is being provided to mothers and newborns in the level 2 M-SNCUs and iKMC wards and to what extent the mothers are adhering to the recommended practices. Secondary Outcomes of Phase 2 measured using patient medical records at one timepoint: Breastfeeding: 1. Proportion of preterm or LBW infants who ar | — |
Countries
India
Contacts
Public ContactAarti Kumar
Outcome results
None listed