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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kangaroo Mother Care (Group-I) | Experimental | In the KMC group mothers were explained detail about KMC adoption in the presence of their family. KMC was initiated as soon as the baby was stable. If the mother is not available initially any of the family members can start KMC. The mother provided skin to skin contact in upright position dressed in a cap, socks, and diaper and supported in the bottom with a sling/binder. Adequate privacy was ensured. Comfortable chairs and beds were provided to the mothers practicing KMC in the nursery. 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. When the baby is not in KMC, the baby was placed in the cot with adequately clothed and covered. A "KMC" chart was given to the mother to keep a record of the duration of kangaroo care provided. If the mother is unable to fill up the chart, it was done by a close family member. |
|
| Standard Method Care (Group-II) | Active Comparator | Neonate in the SMC group was managed under a radiant warmer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kangaroo Mother Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of neonatal deaths within 72 hours after enrollment | 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. | 0-72 hours of age |
| Number of neonatal deaths within 28 days of age | Vital status assessed every 12 hours during hospitalization and via home visit on Day 29. | Enrollment to Day 28 |
| Length of hospital stay from enrollment to discharge | Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records. | Enrollment to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of infants exclusively breastfed at 29 days of age | Assessed via 24-hour feeding recall during home visit. Exclusive breastfeeding means no other liquids or solids except prescribed medicines/supplements. | Day 29 |
| Number of infants with clinically suspected sepsis during hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal satisfaction score with hospital care | Structured interview-based rating of overall hospital care experience by the mother. | At discharge |
| Maternal depressive symptoms using PHQ-9 scale | Mother scores ≥15 considered depressed as per PHQ-9 validated cutoff. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital and Medical Centre | Lahore | Punjab Province | 56300 | Pakistan |
Due to confidentiality
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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
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| Standard Medical Care (SMC) | Other | In well baby nursery, under radiant warmer |
|
Suspected sepsis identified through 12-hourly clinical records and laboratory evaluation based on unit protocol. |
| Enrollment to discharge/Day 28 |
| Day 29 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D060127 | Kangaroo-Mother Care Method |
| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D007224 | Infant Care |
| D002654 | Child Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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