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

Not Applicable

Not yet recruiting

• Conditions: Kangaroo-Mother Care; Preterm Infants

• Registration Number: NCT06707376
• Lead Sponsor: Jouf University

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.

Detailed Description

Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.

Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.

Objectives

* To compare the survival rates of preterm infants (\<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.

* To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.

* To assess the feasibility and acceptability of implementing early KMC in NICUs.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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).

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival Rates	Up to 24 weeks	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.
Incidence of Complications	Up to 24 weeks	Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.