Clinical trial NCT03574350: Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
Official title: Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants Either In Kangaroo Position or in Incubator: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Growth Acceleration
Neurobehavioral Manifestations
Keywords: Kangaroo position
Kinesthetic Stimulation
Kangaroo Mother Care
Bonding
Lead sponsor: Kangaroo Foundation
Sponsor class: OTHER
Collaborators: name: Laval University
name: Hospital Universitario San Ignacio
First posted: 2018-07-02
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two interventions groups of 33 each, participated in the study. The first group received Kinesthetic Stimulation in Kangaroo Position (KSKP) and the second group received Kinesthetic Stimulation In incubator (KSI ), both of the interventions were delivered by parents during the period of hospitalization and at home when the infant was discharged from Hospital until 40 weeks of gestational age.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight gain after randomization up to 5 days
timeFrame: Between randomization and 5 days post randomization
measure: Weight gain after randomization up to 15 days
timeFrame: Between randomization and 15 days post randomization
measure: Weight at 40 weeks of gestational age
timeFrame: at 40 weeks of gestational age
Secondary outcomes:
measure: Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age
timeFrame: after randomization up to 5 days if randomization was made before 5 days of chronological age
measure: Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age
timeFrame: after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age
measure: Weight at 40 weeks if randomization was made before 5 days of chronological age
timeFrame: at 40 weeks of gestational age if randomization was made before 5 days of chronological age
measure: Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
timeFrame: after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
measure: Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
timeFrame: after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
measure: Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age
timeFrame: at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age
measure: Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age
timeFrame: after randomization up to 5 days if randomization was made more than 10 days of chronological age
measure: Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age
timeFrame: after randomization up to 15 days if randomization was made more than 10 days of chronological age
measure: Weight at 40 weeks if randomization was made more than 10 days of chronological age
timeFrame: at 40 weeks of gestational age if randomization was made more than 10 days of chronological age
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Nathalie Charpak
state: Cundinamarca
Study officials:
affiliation: Universidad Piloto de Colombia
name: Andrea C Aldana Acosta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Field T, Diego M, Hernandez-Reif M. Potential underlying mechanisms for greater weight gain in massaged preterm infants. Infant Behav Dev. 2011 Jun;34(3):383-9. doi: 10.1016/j.infbeh.2010.12.001. Epub 2011 May 13.
citation: Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
citation: Guzzetta A, Baldini S, Bancale A, Baroncelli L, Ciucci F, Ghirri P, Putignano E, Sale A, Viegi A, Berardi N, Boldrini A, Cioni G, Maffei L. Massage accelerates brain development and the maturation of visual function. J Neurosci. 2009 May 6;29(18):6042-51. doi: 10.1523/JNEUROSCI.5548-08.2009.