Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants

Not Applicable

Completed

• Conditions: Growth Acceleration; Preterm Infant; Neurobehavioral Manifestations
• Interventions: Behavioral: KS in Kangaroo Position; Behavioral: KS in incubator

• Registration Number: NCT03574350
• Lead Sponsor: Nathalie Charpak

Brief Summary

Kangaroo position (KP), the essential component of the Kangaroo Mother Care (KMC) method, has been increasingly implemented, given the benefits of early skin-to-skin contact on the cerebral maturation of preterm infants. In addition it allows for parents to bond with their infants and humanize the care of fragile infants in neonatal units. Evidence on kinesthetic stimulation (KS) is scarce and currently there is no available evidence on KS during the KP. KS is associated with massage in this paper

Detailed Description

The objective is to study the impact of standardized KS delivered either in KP (KSKP) or in an incubator (KSI) on the early growth of very preterm infants.

Patients and methods: Sixty six newborns ≤32 weeks of gestational age at birth received KS delivered 3 times/day during KP or in an incubator. They were randomized when the infants were considered eligibleto initiate KMC which was part of the routine care for all newborns in the Neonatal Care Unit (NCU). The primary outcome were the weight gain (g/kg/day) between randomization, 5, and 15 days after the start of the intervention and weight at 40 weeks of gestational age (term). The secondary outcomes were the same measures according to the chronological age (days of life) of the infant at randomization.

Study Timeline

• Study Start: 2013-08-15
• Primary Completion: 2016-08-30
• Study Completion: 2018-02-28
• Status Verified: 2018-06
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Preterm infants (GA ≤33 weeks of gestation)
• Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.

Exclusion Criteria

• Infants with congenital anomalies
• Unstable during the first 15 days of life

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KS in Kangaroo Position (KSKP)	KS in Kangaroo Position	KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.
KS in incubator (KSI)	KS in incubator	The infant is in the incubator, unclothed with diaper.

Primary Outcome Measures

Name	Time	Method
Weight gain after randomization up to 5 days	Between randomization and 5 days post randomization	weight gain (g/kg/day)
Weight at 40 weeks of gestational age	at 40 weeks of gestational age	Weight in grames
Weight gain after randomization up to 15 days	Between randomization and 15 days post randomization	weight gain (g/kg/day)

Secondary Outcome Measures

Name	Time	Method
Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age	after randomization up to 5 days if randomization was made more than 10 days of chronological age	Weight gain(g/k/d)
Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age	after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age	Weight gain(g/k/d)
Weight at 40 weeks if randomization was made before 5 days of chronological age	at 40 weeks of gestational age if randomization was made before 5 days of chronological age	Weight in grames
Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age	at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age	Weight in grames
Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age	after randomization up to 5 days if randomization was made before 5 days of chronological age	Weight gain(g/k/d)
Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age	after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age	Weight gain(g/k/d)
Weight at 40 weeks if randomization was made more than 10 days of chronological age	at 40 weeks of gestational age if randomization was made more than 10 days of chronological age	Weight in grames
Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age	after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age	Weight gain(g/k/d)
Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age	after randomization up to 15 days if randomization was made more than 10 days of chronological age	Weight gain(g/k/d)

Trial Locations

Locations (1)

Nathalie Charpak; 🇨🇴 Bogotá, Cundinamarca, Colombia