Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants

NCT06707376 | Completed

• 1 other identifier: 547-10-2024
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.

Conditions

Kangaroo-Mother Care; Preterm Infants

Keywords

Kangaroo-Mother Care; Neonatal Nursing Practices; Preterm Infants

Outcome Measures

Primary Outcomes (2)

• Survival Rates

  Survival Rates will be the proportion of preterm infants who survive following the implementation of KMC, a practice emphasizing continuous skin-to-skin contact and exclusive breastfeeding. For infants weighing less than 2000 grams, KMC has been associated with reduced mortality, particularly in low-resource settings where conventional neonatal care may be limited. By promoting physiological stability, enhancing maternal bonding, and reducing the risk of severe complications like infections and hypothermia, KMC offers a cost-effective and impactful approach to improving survival outcomes in this vulnerable population.

  Up to 24 weeks

• Incidence of Complications

  Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.

  Up to 24 weeks

Study Arms (2)

Early Kangaroo Mother Care Group

EXPERIMENTAL

Early Kangaroo Mother Care Group: * Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants.

Other: Early Kangaroo Mother Care

Control Group

NO INTERVENTION

Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress.

Interventions

Early Kangaroo Mother Care OTHER

* Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants.

Early Kangaroo Mother Care Group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born at \<37 weeks of gestation.
• Birth weight \<2000 grams.
• Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).

You may not qualify if:

• Infants with severe respiratory distress requiring mechanical ventilation.
• Infants with congenital anomalies or other significant health issues.
• Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Tanta University Hospital T

Tanta, Gharbia Governorate, 2014, Egypt

Location

Related Publications (1)

• Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Transforming neonatal nursing: a randomized controlled trial comparing kangaroo care and standard protocols for survival in preterm infants with respiratory distress syndrome. BMC Nurs. 2025 Apr 16;24(1):430. doi: 10.1186/s12912-025-03088-8.

  PMID: 40241073 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to either the Early Kangaroo Mother Care group or control group using a computer-generated randomization sequence with block sizes of varying lengths to ensure allocation concealment and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associtae Professor

Model Details: Early Kangaroo Mother Care Group: * Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants. Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: January 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

EG (1)