Kangaroo Mother CareKMCNCT06338410
Effect of Kangaroo Mother Care on Oxidative Stress and Bonding
A study testing Kangaroo Mother Care in people with Kangaroo Mother Care and Oxidative Stress, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. Read more about this study
- Who is it for?
- Ages 3 to 3 days
- Conditions the study is for
- Kangaroo Mother Care, Oxidative Stress
- What is being tested?
- Kangaroo Mother Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 20 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 3 to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For Pre-term Neonates:
- 24-36 weeks' gestation Premature infants
- Medically stable as determined by a Score of Neonatal Acute Physiology \& Perinatal Extension (SNAPPE-II); pre-term neonates with score of less than 9.
- Both gender
- Weight 1.5kg to 2.499 kg
- For Mothers of Pre-term Neonates:
- 1. Medically stable Mothers.
Who cannot join
- The criteria for exclusion will be as follows:
- For Pre-term Neonates:
- Those will be excluded who are with below given conditions:
- Require any kind of surgery.
- Intraventricular hemorrhage (IVH) > or equal to grade 3.
- On medication such as morphine, fentanyl, midazolam, muscle relaxants, phenobarbital.
Show all 14Show fewer
- Severe cyanotic heart disease or severe RDS.
- Abdominal wall or intestinal anomaly or injury.
- Chromosomal Disorder
- Facial anomaly.
- For Mothers of Pre-term Neonates:
- Mothers having Complications of delivery like Post partem hemorrhage.
- Any acute illness
- Complicated cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Kangaroo Mother Care on Selected Bio Marker and Maternal-Infant Bonding in Preterm Neonates in a Tertiary Care Hospital of Lahore, Pakistan
The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:
- Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?
- Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.
Read more
Participants will be:
- given Kangaroo mother care on third day of life or standard incubator care for one hour
- Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.
- Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care
Read the detailed description
Researcher will follow existing guidelines for shifting of infant from incubator to the mother's chest. The researcher will assist the mothers to have the baby from the incubator and to sit in the special KMC chair and bed. Urine will be collected from premature infants before and after KMC/Incubator care on third day of life by applying urine collection bag. This method is highly successful in collecting urine non-invasively. Collected urine is then placed in ice box till transportation to lab at University of Health sciences(UHS). and stored at -80 °C. After completion of data collection enzyme-linked immunosorbent assay ELISA kit of Oxidative stress biomarker (Allantoin) will be used for checking level of Allantoin in stored samples within a week. Mothers of both the KMC and control groups will be given the Mother-infant bonding scale (MIBS) self-rating instrument on 3rd Day postpartum before and after KMC and incubator care for bonding assessment.
- Conditions
- Kangaroo Mother Care, Oxidative Stress
- Being tested
- Kangaroo Mother Care
- Keywords
- Bonding, Kangaroo mother care, Oxidative Stress, Prematurety, Allantoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareBehavioural
KMC is a care system for LBW and preterm infants at birth, based on skin-to-skin contact between the infant and the mother and exclusive breast feeding. The mother carries her Preterm infant for at least one hour per day. Urine collected before and after skin-to-skin contact.
| Study group | Role | What they receive |
|---|---|---|
| KMC group | Experimental | Premature infants and their mothers who will be provided with kangaroo mother care on third day of life. baby will be placed on bare chest of mother and before and after KMC urine samples will be collected from premature infants. Receives: Behavioral: Kangaroo Mother Care |
| Control group | No intervention | premature infants and their mothers who will be provided with same conventional incubator care in NICU on day third of life their urine samples will also be collected before and after conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants
Biomarker of oxidative stress (Allantoin) in urine samples of premature infants by ELISA Testing before and after one hour session of KMC by ELIZA testing
Measured: OnThird day of life before and after one hour of KMC or Conventional care
Mother- Infant Bonding
by Using Mother Infant bonding self rating scale (MIBS) of eight points descriptors bonding between mother and her infant will be measured. Total scores range from 0 to 24. A high score indicates worst mother to infant bonding.
Measured: OnThird day of life before and after one hour of KMC or Conventional care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Aug 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kangaroo Mother CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Services Hospital, Lahore
- Responsible party
- Principal investigator, Samreen Manzoor, University of Health Sciences Lahore
- Investigators
- Samreen Manzoor, MSN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338410
- Sponsor's protocol ID
- UHS/Education/126-24/131
- Acronym
- KMC
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that will be published in research article. Data will be available to other researchers. data of all participants after analysis will be included in research article.
Publications
Manzoor S, Kausar S, Hanif A, Shahzad F, Farooqi S, Khalid R. "Short-term effects of a single kangaroo mother care session on urinary allantoin and maternal-infant bonding in preterm neonates: a quasi-randomized controlled trial". Sci Rep. 2026 Mar 2;16(1):8636. doi: 10.1038/s41598-026-41614-z.
PubMed 41771956
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Kangaroo Mother Care on Selected Bio Marker and Maternal-Infant Bonding in Preterm Neonates in a Tertiary Care Hospital of Lahore, Pakistan
- ClinicalTrials.gov ID
- NCT06338410
- Acronym / sponsor ID
- KMC / UHS/Education/126-24/131
- Conditions
- Kangaroo Mother Care, Oxidative Stress
- Keywords
- Bonding, Kangaroo mother care, Oxidative Stress, Prematurety, Allantoin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Collaborators
- Services Hospital, Lahore
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 29 Mar 2024 (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 if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:
- Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?
- Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.
Participants will be:
- given Kangaroo mother care on third day of life or standard incubator care for one hour
- Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.
- Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care
Detailed description
Researcher will follow existing guidelines for shifting of infant from incubator to the mother's chest. The researcher will assist the mothers to have the baby from the incubator and to sit in the special KMC chair and bed. Urine will be collected from premature infants before and after KMC/Incubator care on third day of life by applying urine collection bag. This method is highly successful in collecting urine non-invasively. Collected urine is then placed in ice box till transportation to lab at University of Health sciences(UHS). and stored at -80 °C. After completion of data collection enzyme-linked immunosorbent assay ELISA kit of Oxidative stress biomarker (Allantoin) will be used for checking level of Allantoin in stored samples within a week. Mothers of both the KMC and control groups will be given the Mother-infant bonding scale (MIBS) self-rating instrument on 3rd Day postpartum before and after KMC and incubator care for bonding assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KMC group | Experimental | Behavioral: Kangaroo Mother CarePremature infants and their mothers who will be provided with kangaroo mother care on third day of life. baby will be placed on bare chest of mother and before and after KMC urine samples will be collected from premature infants. |
| Control group | No intervention | –premature infants and their mothers who will be provided with same conventional incubator care in NICU on day third of life their urine samples will also be collected before and after conventional care |
Who may qualify
- Ages
- 3 to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- For Pre-term Neonates:
- 1. Medically stable Mothers.
Key exclusion criteria (14 listed)
- Require any kind of surgery.
- Intraventricular hemorrhage (IVH) > or equal to grade 3.
- On medication such as morphine, fentanyl, midazolam, muscle relaxants, phenobarbital.
- Severe cyanotic heart disease or severe RDS.
- Abdominal wall or intestinal anomaly or injury.
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 CareKMC is a care system for LBW and preterm infants at birth, based on skin-to-skin contact between the infant and the mother and exclusive breast feeding. The mother carries her Preterm infant for at least one hour per day. Urine collected before and after skin-to-skin contact. | Behavioural | KMC group |
Primary outcome
biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants
Time frame: OnThird day of life before and after one hour of KMC or Conventional care
Biomarker of oxidative stress (Allantoin) in urine samples of premature infants by ELISA Testing before and after one hour session of KMC by ELIZA testing
Mother- Infant Bonding
Time frame: OnThird day of life before and after one hour of KMC or Conventional care
by Using Mother Infant bonding self rating scale (MIBS) of eight points descriptors bonding between mother and her infant will be measured. Total scores range from 0 to 24. A high score indicates worst mother to infant bonding.
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 1 Apr 2024.
- Derived from this study: PubMed 41771956Manzoor S, Kausar S, Hanif A, Shahzad F, Farooqi S, Khalid R. "Short-term effects of a single kangaroo mother care session on urinary allantoin and maternal-infant bonding in preterm neonates: a quasi-randomized controlled trial". Sci Rep. 2026 Mar 2;16(1):8636. doi: 10.1038/s41598-026-41614-z.
- Individual participant dataSharing planned: Yes. Data that will be published in research article. Data will be available to other researchers. data of all participants after analysis will be included in research article.
Related trials for Kangaroo Mother Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
Not yet recruiting
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
Low Birth Weight Among Neonates
Not yet recruiting
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
Newborn Asphyxia, Hypothermia Neonatal
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.
Samreen Manzoor, MSN principal investigator
Saglik Bilimleri Universitesi
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 in people with Kangaroo Mother Care and Oxidative Stress, 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 7 inclusion and 14 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 1 Apr 2024. 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?
biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants (time frame: OnThird day of life before and after one hour of KMC or Conventional care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338410, which also lists 1 linked publication.
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 1 Apr 2024.