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

NCT03574350 | Completed DMC

• 2 other identifiers: KangarooFxxxxx
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Infant; Growth Acceleration; Neurobehavioral Manifestations

Keywords

Kangaroo position; Kinesthetic Stimulation; Kangaroo Mother Care; Bonding

Outcome Measures

Primary Outcomes (3)

• Weight gain after randomization up to 5 days

  weight gain (g/kg/day)

  Between randomization and 5 days post randomization

• Weight gain after randomization up to 15 days

  weight gain (g/kg/day)

  Between randomization and 15 days post randomization

• Weight at 40 weeks of gestational age

  Weight in grames

  at 40 weeks of gestational age

Secondary Outcomes (9)

• 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 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 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 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 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

Study Arms (2)

KS in Kangaroo Position (KSKP)

EXPERIMENTAL

KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.

Behavioral: KS in Kangaroo Position

KS in incubator (KSI)

ACTIVE COMPARATOR

The infant is in the incubator, unclothed with diaper.

Behavioral: KS in incubator

Interventions

KS in Kangaroo Position BEHAVIORAL

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.

Also known as: KSKP

KS in Kangaroo Position (KSKP)

KS in incubator BEHAVIORAL

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.

Also known as: KSI

KS in incubator (KSI)

Eligibility Criteria

• Age: 30 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nathalie Charpak: lead
• Laval University: collaborator
• Hospital Universitario San Ignacio: collaborator

Study Sites (1)

Nathalie Charpak

Bogotá, Cundinamarca, 110231, Colombia

Location

Related Publications (3)

• 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.

  PMID: 21570125 RESULT

• 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.

  PMID: 16027695 RESULT

• 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.

  PMID: 19420271 RESULT

Related Links

• Kinesthetic stimulation in Kangaroo Position (KSKP)

MeSH Terms

Conditions

Premature Birth; Neurobehavioral Manifestations

Interventions

Incubators

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Andrea C Aldana Acosta, PhD

  Universidad Piloto de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nurses who did anthropometrics measures didn't know the interventions assigned to each participant of the study, because the night shift was in charge of taking the data at 7:00 am in the mornings and the interventions were delivered in the morning shifts from 8:00 am until 5:00 pm. No interventions were delivered in the night.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Andrea Aldana

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 2, 2018
• Study Start: August 15, 2013
• Primary Completion: August 30, 2016
• Study Completion: February 28, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)