CompletedNot Applicable

Effect of Kangaroo Mother Care on Oxidative Stress and Bonding

Pakistan40 participantsStarted 2023-08-01

Plain-language 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. 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

Who can participate

Age range

3 Days – 3 Days

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Require any kind of surgery.
. Intraventricular hemorrhage (IVH) \> or equal to grade 3.
. On medication such as morphine, fentanyl, midazolam, muscle relaxants, phenobarbital.

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

biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants

Timeframe: OnThird day of life before and after one hour of KMC or Conventional care

Mother- Infant Bonding

Timeframe: OnThird day of life before and after one hour of KMC or Conventional care

Trial details

NCT IDNCT06338410

SponsorUniversity of Health Sciences Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-20

View on ClinicalTrials.gov More Kangaroo Mother Care trials