GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial
NCT ID: NCT03677752
Last Updated: 2022-05-09
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
20 participants
INTERVENTIONAL
2018-08-20
2020-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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GP_Posit
Participants allocated to this arm will receive the GP\_Posit intervention.
GP_Posit
Mother-infant dyads allocated to this arm will receive the GP\_Posit intervention. The intervention consists of a guided participation intervention to positioning. Mothers will meet with the intervention nurse twice a week for the two first weeks after birth and then one a week until the infant will reach 35 weeks of gestational age. During these encounters, mothers will learn how to interpret their infant's stress and stability cues and participate in his/her care and positioning while being guided by the intervention nurse.
Control
Participants in the control arm will receive usual care.
No interventions assigned to this group
Interventions
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GP_Posit
Mother-infant dyads allocated to this arm will receive the GP\_Posit intervention. The intervention consists of a guided participation intervention to positioning. Mothers will meet with the intervention nurse twice a week for the two first weeks after birth and then one a week until the infant will reach 35 weeks of gestational age. During these encounters, mothers will learn how to interpret their infant's stress and stability cues and participate in his/her care and positioning while being guided by the intervention nurse.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are 18 years or older
* Are born at 27 0/7 et 31 6/7 weeks of gestation
* Are hospitalized in the NICU for at least 4 weeks
Exclusion Criteria
* Have an instable mental health
* Give their newborn infant for adoption
* Require surgery
* Have intraventricular haemorrhage (IVH) \> grade 2
* Have congenital malformations
18 Years
FEMALE
Yes
Sponsors
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St. Justine's Hospital
OTHER
Responsible Party
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Andréane Lavallée
Student
Principal Investigators
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Marilyn Aita, PhD
Role: STUDY_DIRECTOR
Université de Montréal
Locations
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CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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Lavallee A, Aita M, Bourbonnais A, De Clifford-Faugere G. Effectiveness of early interventions for parental sensitivity following preterm birth: a systematic review protocol. Syst Rev. 2017 Mar 23;6(1):62. doi: 10.1186/s13643-017-0459-x.
Lavallee A, Aita M, Cote J, Bell L, Luu TM. A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 May 26;6:77. doi: 10.1186/s40814-020-00601-5. eCollection 2020.
Other Identifiers
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2017-1540
Identifier Type: -
Identifier Source: org_study_id
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