Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde. It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal emotional status
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2025
CompletedFirst Submitted
Initial submission to the registry
January 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
April 27, 2026
April 1, 2026
1 year
January 16, 2026
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Urinary biomarkers of energy utilization
Urinary xanthine and uric acid levels measured using ELISA kits.
3 hours before and 3 hours after intervention on day 3 of life
Oxidative stress marker
Urinary malondialdehyde level measured using ELISA kits.
3 hours before and 3 hours after intervention on day 3 of life
heart rate
Heart rate measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate
Respiratory rate measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life
temperature
Body temperature measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Secondary Outcomes (1)
maternal emotional status
: 3 hours before and 3 hours after intervention on day 3 of life
Study Arms (2)
study group
EXPERIMENTALbabies at day 3 will have kangro mother care
control group
PLACEBO COMPARATORwill have routine incubator care
Interventions
o All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care. o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding. o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.
o All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care. o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding. o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.
Eligibility Criteria
You may qualify if:
- Preterm neonates (32-36 weeks)
- Vitally stable
- On room air or low ventilatory support
You may not qualify if:
- Neonates requiring surgery
- Intraventricular hemorrhage
- Receiving sedatives (morphine, fentanyl, midazolam)
- Renal impairment
- Congenital anomalies
- Cyanotic heart disease
- Severe respiratory distress
- Hemodynamic instability
- Hypothermia
- Parental refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams university
Cairo, Salam City, 14456, Egypt
Related Publications (1)
Morelius E, Ortenstrand A, Theodorsson E, Frostell A. Early maternal contact has an impact on preterm infants' brain systems that manage stress. Nursing children and young people. 2016; 28: 62-63.
BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant prfessor
Study Record Dates
First Submitted
January 16, 2026
First Posted
April 23, 2026
Study Start
May 15, 2025
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
July 15, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share