Low Birth Weight, Premature Birth, Preterm Infant
Conditions
Keywords
Kangaroo Mother Care, Early Kangaroo Mother Care, Skin-to-Skin Contact, Low Birth Weight Infants, Preterm Neonates, Prematurity, Neonatal Care, Breastfeeding Support
Brief summary
The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight \<2000 g). The study will be conducted among preterm infants admitted to the neonatal unit of Services Hospital Lahore. The main questions it aims to answer are: * Does early kangaroo mother care initiated within the first 24 hours of birth improve neonatal outcomes compared with standard neonatal care? * Does early initiation of kangaroo mother care improve thermal stability, breastfeeding outcomes, and overall clinical recovery in low birth weight preterm infants? Researchers will compare early kangaroo mother care with standard neonatal care to see if early initiation of skin-to-skin contact and breastfeeding support improves neonatal outcomes. Participants will: * Be randomly assigned to receive either early kangaroo mother care or standard neonatal care. * Infants in the intervention group will receive early skin-to-skin contact with the mother or caregiver along with breastfeeding support according to hospital protocols. * Infants in the control group will receive standard neonatal care practices provided in the neonatal unit.
Detailed description
Preterm birth remains the leading cause of mortality among children under five years of age worldwide. Each year approximately 15 million infants are born prematurely, accounting for more than one in ten births globally. Complications related to prematurity contribute substantially to neonatal mortality and long-term morbidity, particularly in low- and middle-income countries. Pakistan has one of the highest reported rates of preterm birth globally, highlighting the urgent need for effective, low-cost neonatal care strategies. Low birth weight (LBW) preterm infants are particularly vulnerable to hypothermia, infection, feeding difficulties, and other complications due to physiologic immaturity. Conventional neonatal care for these infants often relies on incubators, radiant warmers, and specialized monitoring, which may be resource-intensive and difficult to sustain in high-volume public hospitals in low-resource settings. Kangaroo Mother Care (KMC) is a cost-effective and evidence-based intervention designed to improve outcomes for preterm and LBW infants. The intervention consists primarily of continuous or intermittent skin-to-skin contact between the caregiver and infant, promotion of exclusive breastfeeding or breast-milk feeding, early discharge when clinically appropriate, and structured follow-up. Skin-to-skin contact helps maintain thermal stability, enhances breastfeeding success, and strengthens maternal-infant bonding. Previous studies and systematic reviews have demonstrated that KMC can reduce neonatal mortality, improve breastfeeding rates, and decrease the risk of severe infection and hypothermia in LBW infants. Recent research has also explored the potential benefits of early initiation of KMC, including initiation soon after birth rather than after stabilization. The World Health Organization Immediate Kangaroo Mother Care study evaluated continuous KMC initiated shortly after birth in infants with birth weights between 1.0 and 1.799 kg and suggested potential survival benefits. However, further evidence is needed to determine the effectiveness of early KMC initiation in relatively stable LBW infants in routine clinical settings, particularly in low-resource environments. This randomized controlled trial aims to evaluate the effectiveness of early initiation of kangaroo mother care within the first 24 hours after birth compared with standard neonatal care practices in healthy low birth weight preterm infants. Participants randomized to the intervention arm will receive structured early KMC with caregiver skin-to-skin contact and breastfeeding support according to institutional protocols. Infants in the control group will receive standard neonatal care as practiced in the neonatal unit. The study will be conducted at the neonatal care facilities of Services Hospital Lahore. By comparing early KMC with standard care, the trial aims to generate evidence regarding the feasibility and clinical impact of early KMC initiation in a tertiary care hospital in Pakistan. Findings from this study may contribute to strengthening neonatal care policies and support wider implementation of KMC programs in similar healthcare settings.
Interventions
OTHERKangaroo Mother Care
Skin-to-skin contact was given for a minimum of 1 hour at a time and at least for 12 hrs./ day, duration was gradually increased to as long as comfortable to the mother and baby.
In well baby nursery, under radiant warmer
Sponsors
University of Health Sciences Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This randomized controlled trial study was conducted in low birth weight babies admitted in Services Hospital Lahore, Punjab, Pakistan. Inclusion criteria were neonate with birth weight 1250 to 1800 gm., gestational age \>30weeks to \<37 weeks and the hemodynamically stable after birth. A detailed history was taken from the mother/caregiver and from an obstetric record and then entered in the structured questionnaire. Gestational age was determined by best obstetric estimates and new Ballard score. Exclusion criteria were a major life-threatening congenital malformation, severe perinatal asphyxia, babies require a ventilator or inotropic support, the mother is critically ill or unable to comply with the follow-up schedule, parental refusal for KMC intervention. Eligible subjects were selected as per inclusion and exclusion criteria. The subjects were divided into two groups; Kangaroo Mother Care (Group-I) and Standard Method Care (Group-II). Randomization was achieved by lottery techniqu
Eligibility
Sex/Gender
ALL
Age
1 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* New admission of singleton or twin (inborn or out-born) * Weight \< 2000 g (as per study scale) * Age 1-24 h old when screening begins * Gestational age \>30 weeks to \<37 weeks * Mother or other caregiver available and willing to provide intervention
Exclusion criteria
* Triplets who are all admitted to the study site * Congenital malformation not compatible with life or needing immediate surgical intervention * Severe jaundice * Seizures * Stable as assessed during cardio-respiratory screening * Severely unstable as assessed during cardio-respiratory screening or died during screening * Severe perinatal asphyxia * Babies require a ventilator or inotropic support * The mother is critically ill or unable to comply with the follow-up schedule * No study bed available * Neonates/mothers enrolled in another research study * No written informed consent from parent or caregiver within 24 h of admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay from enrollment to discharge | Enrollment to discharge | Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records. |
| Number of neonatal deaths within 72 hours after enrollment | 0-72 hours of age | Vital status will be assessed every 12 hours during hospital stay. Neonatal death is defined as cessation of breathing and circulation confirmed by attending physician. |
| Number of neonatal deaths within 28 days of age | Enrollment to Day 28 | Vital status assessed every 12 hours during hospitalization and via home visit on Day 29. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of infants exclusively breastfed at 29 days of age | Day 29 | Assessed via 24-hour feeding recall during home visit. Exclusive breastfeeding means no other liquids or solids except prescribed medicines/supplements. |
| Number of infants with clinically suspected sepsis during hospital stay | Enrollment to discharge/Day 28 | Suspected sepsis identified through 12-hourly clinical records and laboratory evaluation based on unit protocol. |
Countries
Pakistan
Outcome results
None listed