Effect of KMC on Neurobehavior of Preterm Neonates

Neonatal Neurobehavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740594
• Other study ID #: Effect of KMC on neurobehavior
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Neurobehavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the age of 36 weeks
Primary	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.	the age of 36 weeks
Secondary	Salivary cortisol	measuring salivary cortisol	7 days