Preterm InfantKISONKAPNCT03574350
Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
A study testing KS in Kangaroo Position and KS in incubator in people with Preterm Infant and Growth Acceleration, run by Nathalie Charpak at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 30 to 33 weeks
- Conditions the study is for
- Preterm Infant, Growth Acceleration, Neurobehavioral Manifestations
- What is being tested?
- KS in Kangaroo Position and KS in incubator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteColombia
- Study dates
- 15 Aug 2013to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants (GA ≤33 weeks of gestation)
- Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.
Who cannot join
- Infants with congenital anomalies
- Unstable during the first 15 days of life
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- KS in Kangaroo Position, KS in incubator
- Keywords
- Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding
- Medical subject headings
- Premature Birth, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KS in Kangaroo PositionBehavioural
Also called KSKP
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 incubatorBehavioural
Also called KSI
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.
| Study group | Role | What they receive |
|---|---|---|
| KS in Kangaroo Position (KSKP) | Experimental | KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position. Receives: Behavioral: KS in Kangaroo Position |
| KS in incubator (KSI) | Active comparator | The infant is in the incubator, unclothed with diaper. Receives: Behavioral: KS in incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain after randomization up to 5 days
weight gain (g/kg/day)
Measured: Between randomization and 5 days post randomization
Weight gain after randomization up to 15 days
weight gain (g/kg/day)
Measured: Between randomization and 15 days post randomization
Weight at 40 weeks of gestational age
Weight in grames
Measured: 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
Weight gain(g/k/d)
Measured: 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
Weight gain(g/k/d)
Measured: 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
Weight in grames
Measured: 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
Weight gain(g/k/d)
Measured: 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
Weight gain(g/k/d)
Measured: after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age
Weight in grames
Measured: at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age
Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age
Weight gain(g/k/d)
Measured: after randomization up to 5 days if randomization was made more than 10 days of chronological age
Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age
Weight gain(g/k/d)
Measured: after randomization up to 15 days if randomization was made more than 10 days of chronological age
Weight at 40 weeks if randomization was made more than 10 days of chronological age
Weight in grames
Measured: at 40 weeks of gestational age if randomization was made more than 10 days of chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start15 Aug 2013
- Primary completion30 Aug 2016
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathalie Charpak
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Hospital Universitario San Ignacio
- Responsible party
- Sponsor-investigator, Nathalie Charpak, Kangaroo Foundation
- Investigators
- Andrea C Aldana Acosta, PhD, Principal investigator, Universidad Piloto de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574350
- Sponsor's protocol ID
- KangarooF
- Other IDs
- xxxxx
- Acronym
- KISONKAP
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21570125Diego 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.
PubMed 16027695Guzzetta 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.
PubMed 19420271
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03574350
- Acronym / sponsor ID
- KISONKAP / KangarooF
- Keywords
- Kangaroo position, Kinesthetic Stimulation, Kangaroo Mother Care, Bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nathalie CharpakUniversity, hospital or other
- Collaborators
- Laval University, Hospital Universitario San Ignacio
- Study start
- 15 Aug 2013 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| KS in Kangaroo Position (KSKP) | Experimental | Behavioral: KS in Kangaroo PositionKS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position. |
| KS in incubator (KSI) | Active comparator | Behavioral: KS in incubatorThe infant is in the incubator, unclothed with diaper. |
Who may qualify
- Ages
- 30 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants (GA ≤33 weeks of gestation)
- Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.
Key exclusion criteria (2 listed)
- Infants with congenital anomalies
- Unstable during the first 15 days of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KS in Kangaroo PositionAlso: KSKPKSKP 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. | Behavioural | KS in Kangaroo Position (KSKP) |
| KS in incubatorAlso: KSIThe 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. | Behavioural | KS in incubator (KSI) |
Primary outcome
Weight gain after randomization up to 5 days
Time frame: Between randomization and 5 days post randomization
weight gain (g/kg/day)
Weight gain after randomization up to 15 days
Time frame: Between randomization and 15 days post randomization
weight gain (g/kg/day)
Weight at 40 weeks of gestational age
Time frame: at 40 weeks of gestational age
Weight in grames
9 secondary outcomes
Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age
Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age
Time frame: at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age
Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age
Time frame: after randomization up to 5 days if randomization was made more than 10 days of chronological age
Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age
Time frame: after randomization up to 15 days if randomization was made more than 10 days of chronological age
Weight at 40 weeks if randomization was made more than 10 days of chronological age
Time frame: at 40 weeks of gestational age if randomization was made more than 10 days of chronological age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Results publication: PubMed 21570125Field 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.
- Results publication: PubMed 16027695Diego 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.
- Results publication: PubMed 19420271Guzzetta 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.
- Kinesthetic stimulation in Kangaroo Position (KSKP)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C Aldana Acosta, PhD principal investigator
Universidad Piloto de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KS in Kangaroo Position and KS in incubator in people with Preterm Infant and Growth Acceleration, run by Nathalie Charpak at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain after randomization up to 5 days (time frame: Between randomization and 5 days post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574350, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.