Effect of Kangaroo Mother Care on Oxidative Stress and Bonding

NCT06338410 | Completed DMC

• 1 other identifier: UHS/Education/126-24/131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Kangaroo Mother Care; Oxidative Stress

Keywords

Bonding; Kangaroo mother care; Oxidative Stress; Prematurety; Allantoin

Outcome Measures

Primary Outcomes (2)

• 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

  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.

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

Study Arms (2)

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.

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

Interventions

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.

KMC group

Eligibility Criteria

• Age: 3 Days - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For Pre-term Neonates:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead
• Services Hospital, Lahore: collaborator

Study Sites (1)

Services Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Samreen Manzoor, MSN

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: August 1, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication data will be available and available till infinite time
• Access Criteria: criteria will be uploaded after the publication of this research

Locations

PA (1)