Effect of Kangaroo Mother Care on Oxidative Stress and Bonding

NCT ID: NCT06338410

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-20

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KMC group

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.

Group Type: EXPERIMENTAL

Kangaroo Mother Care

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kangaroo Mother Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• For Pre-term Neonates:

1. 24-36 weeks' gestation Premature infants

2. Medically stable as determined by a Score of Neonatal Acute Physiology & Perinatal Extension (SNAPPE-II); pre-term neonates with score of less than 9.

3. Both gender

4. Weight 1.5kg to 2.499 kg

For Mothers of Pre-term Neonates:

1. 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:

1. Require any kind of surgery.

2. Intraventricular hemorrhage (IVH) > or equal to grade 3.

3. On medication such as morphine, fentanyl, midazolam, muscle relaxants, phenobarbital.

4. Severe cyanotic heart disease or severe RDS.

5. Abdominal wall or intestinal anomaly or injury.

6. Chromosomal Disorder

7. Facial anomaly.

For Mothers of Pre-term Neonates:

1. Mothers having Complications of delivery like Post partem hemorrhage.

2. Any acute illness

3. Complicated cesarean section

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Services Hospital, Lahore

OTHER_GOV

Sponsor Role: collaborator

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Samreen Manzoor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samreen Manzoor, MSN

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

Services Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

UHS/Education/126-24/131

Identifier Type: -

Identifier Source: org_study_id