Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
NCT ID: NCT03574350
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2013-08-15
2018-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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KS in Kangaroo Position (KSKP)
KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.
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 (KSI)
The infant is in the incubator, unclothed with diaper.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.
Exclusion Criteria
* Unstable during the first 15 days of life
30 Weeks
33 Weeks
ALL
No
Sponsors
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Laval University
OTHER
Hospital Universitario San Ignacio
OTHER
Nathalie Charpak
OTHER
Responsible Party
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Nathalie Charpak
Dr Andrea Aldana
Principal Investigators
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Andrea C Aldana Acosta, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Piloto de Colombia
Locations
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Nathalie Charpak
Bogotá, Cundinamarca, Colombia
Countries
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References
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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.
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.
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.
Related Links
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Kinesthetic stimulation in Kangaroo Position (KSKP)
Other Identifiers
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xxxxx
Identifier Type: OTHER
Identifier Source: secondary_id
KangarooF
Identifier Type: -
Identifier Source: org_study_id
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