Skip to main content
OpenTrials
Completed

NCT Number: NCT06338410

Effect of Kangaroo Mother Care on Oxidative Stress and Bonding

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • Medically stable Mothers.

Exclusion criteria

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.
  • 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

Treatment and study plan

Kangaroo Mother Care

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Collaborators

  • Services Hospital, Lahore

Registry information

Official study 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

Acronym: KMC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.