Clinical trial NCT06338410: Effect of Kangaroo Mother Care on Oxidative Stress and Bonding
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kangaroo Mother Care
Oxidative Stress
Keywords: Bonding
Kangaroo mother care
Oxidative Stress
Prematurety
Allantoin
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
Collaborators: name: Services Hospital, Lahore
First posted: 2024-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
measure: Mother- Infant Bonding
timeFrame: OnThird day of life before and after one hour of KMC or Conventional care
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital, Lahore
state: Punjab
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Samreen Manzoor, MSN
role: PRINCIPAL_INVESTIGATOR
References: