Effect of KMC on Neurobehavior of Preterm Neonates

NCT03740594 | Completed

• 1 other identifier: Effect of KMC on neurobehavior
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Neurobehavior

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Salivary cortisol

  7 days

Study Arms (3)

KMC 60 min group

ACTIVE COMPARATOR

Behavioral: KMC

KMC 120 min group

ACTIVE COMPARATOR

Behavioral: KMC

control group

ACTIVE COMPARATOR

Behavioral: KMC

Interventions

KMC BEHAVIORAL

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

KMC 120 min group; KMC 60 min group; control group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 14, 2018
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share