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

Preterm Infant Clinical Trial

— KISONKAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574350
• Other study ID #: KangarooF
• Secondary ID: xxxxx
• Status: Completed
• Phase: N/A
• Start date: August 15, 2013
• Est. completion date: February 28, 2018

Study information

• Verified date: June 2018
• Source: Kangaroo Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 28, 2018
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Growth Acceleration
• Neurobehavioral Manifestations
• Premature Birth
• Preterm Infant

Intervention

Behavioral:
• KS in Kangaroo Position
KSKP was applied daily at regular interval corresponding to the presence of parents. Our protocol is based on the Tiffany Field's protocol with some adjustments corresponding to the constraints of the hospital : the KS was applied 3 times a day and during 15 consecutive days in the hospital or at home and parents were responsible of delivering the intervention. Sunflower oil was used. During the first 5 days, parents performed KSKP with the support of the psychologist. After day 5, parents were expected to perform KSKP by themselves but could ask for help at any moment while in hospital or in the ambulatory follow-up. The KS always began approximately 60 minutes after the feed.
• KS in incubator
The infant is in the incubator, unclothed with diaper. Parents delivered KSI with the infant in supine position, stroking with the flats of the fingers with moderate pressure. Five 1-minute intervals, consisting of six 10-s periods of stroking, were applied to the following body regions: head, back, both legs and arms. The same process was repeated in prone position. The last part of the intervention was composed of 6 flexions of each extremity.

Locations

Country	Name	City	State
Colombia	Nathalie Charpak	Bogotá	Cundinamarca

Sponsors (3)

Lead Sponsor	Collaborator
Nathalie Charpak	Hospital Universitario San Ignacio, Laval University

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain after randomization up to 5 days	weight gain (g/kg/day)	Between randomization and 5 days post randomization
Primary	Weight gain after randomization up to 15 days	weight gain (g/kg/day)	Between randomization and 15 days post randomization
Primary	Weight at 40 weeks of gestational age	Weight in grames	at 40 weeks of gestational age
Secondary	Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age	Weight gain(g/k/d)	after randomization up to 5 days if randomization was made before 5 days of chronological age
Secondary	Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age	Weight gain(g/k/d)	after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age
Secondary	Weight at 40 weeks if randomization was made before 5 days of chronological age	Weight in grames	at 40 weeks of gestational age if randomization was made before 5 days of chronological age
Secondary	Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age	Weight gain(g/k/d)	after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age
Secondary	Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age	Weight gain(g/k/d)	after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Secondary	Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age	Weight in grames	at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age
Secondary	Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age	Weight gain(g/k/d)	after randomization up to 5 days if randomization was made more than 10 days of chronological age
Secondary	Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age	Weight gain(g/k/d)	after randomization up to 15 days if randomization was made more than 10 days of chronological age
Secondary	Weight at 40 weeks if randomization was made more than 10 days of chronological age	Weight in grames	at 40 weeks of gestational age if randomization was made more than 10 days of chronological age

External Links

•   Kinesthetic stimulation in Kangaroo Position (KSKP)