Low Birth Weight Among NeonatesNCT07736274
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
A study testing Kangaroo Mother Care and Conventional Neonatal Care in people with Low Birth Weight Among Neonates, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
Trial summary
Kangaroo Mother Care is a novel intervention known to improve survival, nutrition and prevent infections. Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is… Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Low Birth Weight Among Neonates
- What is being tested?
- Kangaroo Mother Care and Conventional Neonatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of age 1-6 hours, both genders Delivered >32 weeks of gestation (as per maternal record) Delivered either via cesarean section or vaginal delivery With low birth weight (1500-2000 grams)
Who cannot join
- Children with major congenital disorder, cleft lip and palate, cyanotic heart disease, congenital anomaly,
- Having chromosomal abnormality or Down's score >7 at admission
- Neonates of birth weight <1500 grams, need NICU admission for surfactant or resuscitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PNS Shifa Hospital Karachi
Karachi, Sindh, 75557
Dr Ehsan Qadir, FCPS Paediatrics/ Neonatology, +923467771482, ehsanqadirdr@gmail.com
About this study
Kangaroo Mother Care is a novel intervention known to improve survival, nutrition and prevent infections. Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier.Studies have shown that kangaroo mother care has benefits for infants and mothers, including reduction in infant mortality rate, maintenance of the neonate's temperature and promoting breastfeeding. Kangaroo mother care also improves the infant's respiratory rate, oxygen saturation, weight gain, sleeping condition and physical growth. It has a positive effect on physical growth and motor development of newborns. Kangaroo mother care decreases the neonates need for phototherapy and repeated admission for neonatal jaundice in low birth weight infants. The objective of study is to compare the outcome with and without kangaroo mother care in neonates with low birth weight.
- Conditions
- Low Birth Weight Among Neonates
- Being tested
- Kangaroo Mother Care, Conventional Neonatal Care
- Keywords
- Neonates, Kangaroo Mother Care, Birth weight
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareBehavioural
Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier
Conventional Neonatal CareOther
Conventional pharmacotherapy and supportive care provided in low birth weight neonates
| Study group | Role | What they receive |
|---|---|---|
| Group A, neonates will be given kangaroo mother care | Experimental | Not described Receives: Behavioral: Kangaroo Mother Care |
| Group B, neonates will be given conventional neonatal care | Active comparator | Not described Receives: Other: Conventional Neonatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weight Gain
It will be calculated in terms of g/day as difference in weight before and after 40 days of trial, divided by 40 (number of days)
Measured: 40 days
Mean Head Circumference Gain
It will be calculated in terms of cm/week as difference in weight before and after 40 days of trial, divided by 6 (weeks during 40 days)
Measured: 6 weeks
Hypothermia
It will be labeled if body temperature falls below 98.6oF at any point during follow-up of 40 days
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight Among NeonatesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Navy Station Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hina Baby, Pakistan Navy Station Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736274
- Sponsor's protocol ID
- 26
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
- ClinicalTrials.gov ID
- NCT07736274
- Acronym / sponsor ID
- 26
- Conditions
- Low Birth Weight Among Neonates
- Keywords
- Neonates, Kangaroo Mother Care, Birth weight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pakistan Navy Station Shifa HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Jul 2026 (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.
Kangaroo Mother Care is a novel intervention known to improve survival, nutrition and prevent infections. Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier.Studies have shown that kangaroo mother care has benefits for infants and mothers, including reduction in infant mortality rate, maintenance of the neonate's temperature and promoting breastfeeding. Kangaroo mother care also improves the infant's respiratory rate, oxygen saturation, weight gain, sleeping condition and physical growth. It has a positive effect on physical growth and motor development of newborns. Kangaroo mother care decreases the neonates need for phototherapy and repeated admission for neonatal jaundice in low birth weight infants. The objective of study is to compare the outcome with and without kangaroo mother care in neonates with low birth weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, neonates will be given kangaroo mother care | Experimental | Behavioral: Kangaroo Mother Care |
| Group B, neonates will be given conventional neonatal care | Active comparator | Other: Conventional Neonatal Care |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates of age 1-6 hours, both genders Delivered >32 weeks of gestation (as per maternal record) Delivered either via cesarean section or vaginal delivery With low birth weight (1500-2000 grams)
Key exclusion criteria (3 listed)
- Children with major congenital disorder, cleft lip and palate, cyanotic heart disease, congenital anomaly,
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 CareKangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier | Behavioural | Group A, neonates will be given kangaroo mother care |
| Conventional Neonatal CareConventional pharmacotherapy and supportive care provided in low birth weight neonates | Other | Group B, neonates will be given conventional neonatal care |
Primary outcome
Mean Weight Gain
Time frame: 40 days
It will be calculated in terms of g/day as difference in weight before and after 40 days of trial, divided by 40 (number of days)
Mean Head Circumference Gain
Time frame: 6 weeks
It will be calculated in terms of cm/week as difference in weight before and after 40 days of trial, divided by 6 (weeks during 40 days)
Hypothermia
Time frame: 40 days
It will be labeled if body temperature falls below 98.6oF at any point during follow-up of 40 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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.
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 Conventional Neonatal Care in people with Low Birth Weight Among Neonates, run by Pakistan Navy Station Shifa Hospital 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hina Baby, MBBS (+923053009768, Shaikhhinababy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weight Gain (time frame: 40 days). 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 30 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.