Effect of KMC on Neurobehavior of Preterm Neonates

Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03740594

Enrollment

120

Registered

2018-11-14

Start date

2016-08-01

Completion date

2018-02-01

Last updated

2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Neurobehavior

Brief summary

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.

Interventions

BEHAVIORALKMC

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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.

Design outcomes

Primary

Measure	Time frame	Description
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)	the age of 36 weeks	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.

Secondary

Measure	Time frame	Description
Salivary cortisol	7 days	measuring salivary cortisol

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026