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GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial

S

St. Justine's Hospital

Status

Completed

Conditions

Child Development
Interaction, Mother-Infant
Preterm Infant
Parent-Child Relations
Mothers

Treatments

Other: GP_Posit

Study type

Interventional

Funder types

Other

Identifiers

NCT03677752
2017-1540

Details and patient eligibility

About

The aim of this study is to evaluate the acceptability, feasibility and preliminary effects a GP_Posit intervention. GP_Posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. Preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

This study will recruit mother-infant dyads.

Inclusion Criteria for mothers:

  • Understand, write and read French and/or English
  • Are 18 years or older

Exclusion Criteria for mothers:

  • Use drugs
  • Have an instable mental health
  • Give their newborn infant for adoption

Inclusion Criteria for preterm infants:

  • 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 for preterm infants:

  • Require surgery
  • Have intraventricular haemorrhage (IVH) > grade 2
  • Have congenital malformations

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

GP_Posit
Experimental group
Description:
Participants allocated to this arm will receive the GP_Posit intervention.
Treatment:
Other: GP_Posit
Control
No Intervention group
Description:
Participants in the control arm will receive usual care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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