Implementing Kangaroo Mother Care soon after birth in district hospitals

Not yet recruiting

Conditions: Preterm / Low birth weight newborn babies
Other problems with newborn,

Registration Number: CTRI/2023/03/050420

Lead Sponsor: Centre for Health Research and Development Society for Applied Studies

Brief Summary: Annually 20 million are born with low birth weight(LBW) as a result ofbeing delivered as small for gestational age or preterm About 32 million are born small forgestational age and 15 million are born preterm. These newbornsare vulnerable to an increased risk of death and development challenges. Thesevulnerable newborns not only account for 80% of all neonatal deaths but alsoare at increased risk of short- and long-term respiratory, infectious,metabolic and neurological morbidities, with higher risks of adverse outcomesseen at lower gestational ages.

KMC is defined as early, prolonged, and continuousskin-to-skin contact between mother and her preterm or LBW newborn, andexclusive breastfeeding or breastmilk feeding. In 2016 a Cochrane reviewreported on 21 randomized controlled trials (3042 infants) that compared KMC withconventional neonatal care in health facilities and showed that KMC reducedmortality by 40% (RR 0.60, 95% CI 0.39 to 0.92), nosocomial infections by 65%(RR 0.45, 95% CI 0.27 to 0.76) and hypothermia by 64% (RR 0.34, 95% CI 0.17 to0.67). It was also reported that KMC increased weight, length, and headcircumference, breastfeeding, mother satisfaction with the method of infantcare and maternal-infant attachment, and improved child development

KMC initiated immediately after birth for 1.0 to<1.8 kg infants significantly reduced the risk of neonatal death by 25%.Scale-up KMC study showed that with a committed workforce, respectful maternitycare and government leadership, KMC coverage could increase to 80%. Theevidence of the efficacy of iKMC is clear. IKMC reduces mortality in LBW babiesby 25%. The number neededto treat is 27, which means that the intervention provided to 27 LBW babieswill save one life. Globally, there are about 4 million babies (of the 20million LBW babies) that would be eligible for this intervention. If all thesebabies received iKMC, about 150,000 lives would be saved every year. The keyissue is to achieve high-quality, universal coverage of iKMC in the targetpopulation.

WHO recommendations for the care of the preterm andLBW baby have recently been updated, and this update takes intoconsideration all the new evidence on the trilogy of KMC, including that onscale-up of facility-KMC, community-initiated KMC, and iKMC as mentioned above.

The India newborn action plan (INAP) recommendedestablishment of fully functional KMC wards in health facilities. The Ministry of Health and Family Welfare(MoHFW) allotted funds to states to create KMC spaces within the specialnewborn care units (SNCUs), with 90% KMC coverage targets by 2030 (MoHFW,2014).

Haryana government has always been in theforefront, proactively taking actions to improve of maternal, newborn and childhealth in the state. The department of Health in Haryana has developed amodel for comprehensive care of small and sick neonates which is currentlyimplemented in 9 districts, and the government is in agreement to partner withthe local research organization, Centre of Health Research and Development,Society for Applied Studies (CHRD SAS), to build an effective and efficientmodel for care of small sick newborns through the proposedimplementation research. A consortium has been formed by CHRD SAS, theteam from Safdarjung hospital, that pioneered the M-NICU in Delhi for theimmediate KMC randomized controlled trial, and the Translational Health Scienceand Technology Institute (THSTI) to scale up the immediate KMC in selecteddistricts in Haryana. The Government program managers and researchers willjointly make up the study team. Safdarjung Hospital (SJH), the only site inAsia that contributed to 43% sample size for the multi-center study onimmediate KMC. The Mother-Newborn Care Unit (MNICU) was designed by theSJH-THSTI technical team. The SJH-THSTI team will be responsible for developingthe intervention and implementation strategy for the district hospitals. SJHwill serve as a demonstration site and training center, with on-site trainingsupport for the district pool of trainers and government personnel responsiblefor program implementation. They will also conduct periodic meetings with thegovernment personnel to review the progress and work together to resolvebarriers.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Preterm or LBW newborns (gestational age <37 weeks or birthweight<2.5 kg) requiring care in the SNCU, i.e., who are below the country cut-off point for birthweight or gestational age for SNCU admission, or those preterm or LBW newborns who are above the cut-off but are sick and need SNCU admission.

Exclusion Criteria

Preterm or LBW newborns requiring SNCU care who are critically sick, for 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) in the first 2 hours of birth or are receiving mechanical ventilation (invasive mechanical ventilation) in the first 2 hours of birth; 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 These neonates (except deceased newborns) will be excluded from the study for outcome measurement purposes however they all newborns will receive appropriate care in the iKMC implementing facility.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of preterm or LBW infants who died during the first 28 days of life (among the trial participants). The primary outcome will be analysed globally in the 24 clusters	29th day of life

Secondary Outcome Measures

Name	Time	Method
Breastfeeding:	1. Proportion of preterm or LBW infants who are exclusively breastfed at discharge from trial facilities
Proportion of preterm or LBW infants with clinical sepsis: As diagnosed by the attending physician either defined by clinical signs alone or presence of clinical signs with positive laboratory screening test while in M-SNCU/SNCU	From day of birth till time of discharge
Proportion of preterm or LBW infants who has hypoglycaemia: Any blood glucose level of less than 45 mg per deciliter, measured when clinically indicated during M-SNCU/SNCU stay, as per the SNCU protocol of each study	From day of birth till time of discharge
Proportion of preterm or LBW infants who has hypothermia: Any axillary temperature less than 36Â°C during M-SNCU/SNCU stay	From day of birth till time of discharge
Proportion of preterm or LBW infants receiving KMC at discharge (8-24 hours of skin-to-skin contact in the 24 hours and exclusively breastfed) before discharge from the trial facility	From day of birth till time of discharge

Trial Locations

Locations (1): Civil Hospital Ambala City
🇮🇳
Ambala, HARYANA, India
Civil Hospital Ambala City
🇮🇳Ambala, HARYANA, India
Dr Sarmila Mazumder
Principal investigator
011-46043751
sarmila.mazumder@sas.org.in