Low Birth WeightNCT07259486
Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
A study testing Kangaroo Mother Care and Standard Medical Care (SMC) in people with Low Birth Weight and Premature Birth, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Low Birth Weight, Premature Birth, Preterm Infant
- What is being tested?
- Kangaroo Mother Care and Standard Medical Care (SMC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Hospital and Medical Centre
Lahore, Punjab Province, 56300
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Low Birth Weight, Premature Birth, Preterm Infant
- Being tested
- Kangaroo Mother Care, Standard Medical Care (SMC)
- Keywords
- Kangaroo Mother Care, Early Kangaroo Mother Care, Skin-to-Skin Contact, Low Birth Weight Infants, Preterm Neonates, Prematurity, Neonatal Care, Breastfeeding Support
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareOther
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.
Standard Medical Care (SMC)Other
In well baby nursery, under radiant warmer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kangaroo Mother Care |
| Standard Method Care (Group-II) | Active comparator | Neonate in the SMC group was managed under a radiant warmer. Receives: Other: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Enrollment to discharge
Secondary outcomes (2)
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.
Measured: Day 29
Number of infants with clinically suspected sepsis during hospital stay
Suspected sepsis identified through 12-hourly clinical records and laboratory evaluation based on unit protocol.
Measured: Enrollment to discharge/Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Mar 2022
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komal Khadim Hussain, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259486
- Sponsor's protocol ID
- IRB/2022/921/SIMS
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07259486
- Acronym / sponsor ID
- IRB/2022/921/SIMS
- Conditions
- Low Birth Weight, Premature Birth, Preterm Infant
- Keywords
- Kangaroo Mother Care, Early Kangaroo Mother Care, Skin-to-Skin Contact, Low Birth Weight Infants, Preterm Neonates, Prematurity, Neonatal Care, Breastfeeding Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Mother Care (Group-I) | Experimental | Other: Kangaroo Mother CareIn 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 | Other: Standard Medical Care (SMC)Neonate in the SMC group was managed under a radiant warmer. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Mother CareSkin-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. | Other | Kangaroo Mother Care (Group-I) |
| Standard Medical Care (SMC)In well baby nursery, under radiant warmer | Other | Standard Method Care (Group-II) |
Primary outcome
Number of neonatal deaths within 72 hours after enrollment
Time frame: 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
Time frame: Enrollment to Day 28
Vital status assessed every 12 hours during hospitalization and via home visit on Day 29.
Length of hospital stay from enrollment to discharge
Time frame: Enrollment to discharge
Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records.
2 secondary outcomes
Number of infants exclusively breastfed at 29 days of age
Time frame: Day 29
Number of infants with clinically suspected sepsis during hospital stay
Time frame: Enrollment to discharge/Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. Due to confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Mother Care and Standard Medical Care (SMC) in people with Low Birth Weight and Premature Birth, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonatal deaths within 72 hours after enrollment (time frame: 0-72 hours of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.