NCT07548229

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
May 2025Jul 2026

Study Start

First participant enrolled

May 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 16, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

kangrooneonates

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

EXPERIMENTAL

babies at day 3 will have kangro mother care

Behavioral: kangroo mother care

control group

PLACEBO COMPARATOR

will have routine incubator care

Behavioral: routine incubation 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.

study group

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.

control group

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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

Locations