Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birt… (NCT07259486) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
Pakistan100 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range
1 Hour – 24 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of neonatal deaths within 72 hours after enrollment
Timeframe: 0-72 hours of age
2
Number of neonatal deaths within 28 days of age
Timeframe: Enrollment to Day 28
3
Length of hospital stay from enrollment to discharge