Child Development, Interaction, Mother-Infant, Mothers, Parent-Child Relations, Preterm Infant
Conditions
Keywords
Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit
Brief summary
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.
Interventions
OTHERGP_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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to the protocole | Through study completion, an average of 1 1/2 year. | Compliance to the protocole to assess feasibility of the intervention GP\_Posit and protocol. Research team will document aspects regarding % of recruitment, % of intervention delivered as planned, etc. through study completion. A threshold of 80% will be used to determine feasibility of the protocole elements. |
| Content analysis of acceptability questionnaires | When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | Mothers' answers to acceptability questionnaires will be analyzed. This is a questionnaire built by the research team aimed at collecting narrative data regarding mother's acceptability of the intervention. Elements such as acceptability of the length of the intervention, frequency of encounters, etc. will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental beliefs about preterm infant and parental role | At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | Neonatal intensive care unit: parental beliefs scale (NICU:PBS). Scale range: Likert type scale (1 to 5) where a higher score indicates better beliefs. Scores can vary from 18 to 90. |
| Electroencephalogram (EEG) | At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | Electrical activity in the preterm brain will be measured using 8 electrodes on the infant's heads and compared before and after the intervention + between groups. We will perform spectral analyses with multiscale entropy calculation and connectivity analyses in order to see synchrony using the phase slope index. |
| General movement assessment (GMA) | When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment. |
| Mother-Infant interaction | When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge) | Filmed mother-infant feeding will be coded to assess mother-infant interaction between the mother and the infant and maternal sensitivity to her infant's cues using the Parent-Child Interaction - Feeding Scale. The score can vary from 0-76 and a higher score is better. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal Anxiety | At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | State-trait anxiety inventory (STAI). Likert type scale with scores ranging from 1 to 4. A higher score indicates a worst outcome (more anxiety). Total score can range from 20 to 80. |
| Maternal stress | At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge) | Parental stressor scale: NICU Scale range: Likert type scale (1 to 5) where a higher score indicates higher levels of stress. The three subscales will be reported independently. First subscale can vary from 0 to 25. Second subscale can vary from 0 to 70. Third subscale can vary from 0 to 35. |
Countries
Canada
Outcome results
None listed