NCT03740594 - Effect of KMC on Neurobehavior of Preterm Neonates | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Neonatal Neurobehavior

Interventions

KMCBEHAVIORAL

Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9.

Time frame: the age of 36 weeks

Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9. For stress, lethargy, non-optimal response and asymmetic reflexes, the higher the seb-scale, the worse. In other sub-scales, the higher the scale, the better.

Time frame: the age of 36 weeks

Secondary Outcomes

Salivary cortisol

measuring salivary cortisol

Time frame: 7 days