Effect of KMC on Neurobehavior of Preterm Neonates

Ain Shams University

Status: Completed

Conditions: Neonatal Neurobehavior

Treatments: Behavioral: KMC

Study type: Interventional

Funder types: Other

Identifiers

NCT03740594

Effect of KMC on neurobehavior

Details and patient eligibility

About

This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.

Enrollment: 120 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable preterm neonates with gestational age between 31 and 35 weeks.

Exclusion criteria

• Neonates with major congenital birth defects or chromosomal anomalies.
• Perinatal asphyxia and intra-ventricular hemorrhage.
• Hemodynamically significant cardiac abnormalities.
• Neonates received postnatal steroids.
• Neonates whose mothers had a history of drug abuse during pregnancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

KMC 60 min group

Active Comparator group

Treatment:

Behavioral: KMC

KMC 120 min group

Active Comparator group

Treatment:

Behavioral: KMC

control group

Active Comparator group

Treatment:

Behavioral: KMC