Preterm Infant Clinical Trial
— KISONKAPOfficial 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
Verified date | June 2018 |
Source | Kangaroo Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Nathalie Charpak | Bogotá | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
Nathalie Charpak | Hospital Universitario San Ignacio, Laval University |
Colombia,
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
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 |
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