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Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates

Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07548229
Enrollment
60
Registered
2026-04-23
Start date
2025-05-15
Completion date
2026-08-15
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact of Kangroo on Neonates

Keywords

kangroo, neonates

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

Detailed description

This randomized controlled clinical trial aims to evaluate the effect of kangaroo mother care on energy utilization and oxidative stress in preterm neonates admitted to the neonatal intensive care unit (NICU) at Ain Shams University Children's Hospital, Cairo, Egypt. Preterm neonates with gestational age between 32 and 36 weeks who meet the eligibility criteria will be enrolled and randomly assigned into two groups: an intervention group receiving kangaroo mother care and a control group receiving routine incubator care. All enrolled neonates will receive routine incubator care until day 3 of life. On day 3, the intervention group will receive one hour of kangaroo mother care provided by the mother after feeding, while the control group will receive one hour of standard nursing care without kangaroo mother care. Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and temperature, will be monitored at baseline and every 15 minutes during the intervention period. Urine samples will be collected from neonates 3 hours before and 3 hours after the intervention to measure biomarkers of energy utilization (xanthine and uric acid) and oxidative stress (malondialdehyde) using ELISA kits. Maternal emotional status will be assessed before and after the intervention period. The study is conducted following approval from the Research Ethics Committee of Ain Shams University, and informed consent will be obtained from parents or legal guardians prior to participation.

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.

BEHAVIORALroutine incubation care

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes

Inclusion criteria

* Preterm neonates (32-36 weeks) * Vitally stable * On room air or low ventilatory support

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Urinary biomarkers of energy utilization3 hours before and 3 hours after intervention on day 3 of lifeUrinary xanthine and uric acid levels measured using ELISA kits.
Oxidative stress marker3 hours before and 3 hours after intervention on day 3 of lifeUrinary malondialdehyde level measured using ELISA kits.
heart rateBaseline and every 15 minutes during 1 hour intervention on day 3 of lifeHeart rate measured using standard neonatal monitoring devices.
Respiratory rateBaseline and every 15 minutes during 1 hour intervention on day 3 of lifeRespiratory rate measured using standard neonatal monitoring devices.
temperatureBaseline and every 15 minutes during 1 hour intervention on day 3 of lifeBody temperature measured using standard neonatal monitoring devices.

Secondary

MeasureTime frameDescription
maternal emotional status: 3 hours before and 3 hours after intervention on day 3 of lifeIt will be assessed by validated Arabic questionnaire

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026