Clinical trial NCT06707376: Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
Official title: Early Kangaroo Mother Care Versus Standard Neonatal Nursing Practices: A Randomized Controlled Trial on Survival and Nursing Outcomes in Preterm Infants (<2000 g) With Mild to Moderate Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kangaroo-Mother Care
Preterm Infants
Keywords: Kangaroo-Mother Care
Neonatal Nursing Practices
Preterm Infants
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 240
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

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).

Primary outcomes:
measure: Survival Rates
timeFrame: Up to 24 weeks
measure: Incidence of Complications
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital T
state: Gharbia Governorate
Study officials:
References: