Preterm InfantGP_PositNCT03677752
GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial
A study testing GP_Posit in people with Preterm Infant and Mothers, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Mothers, Parent-Child Relations
- What is being tested?
- GP_Posit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2018to 29 May 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand, write and read French and/or English
- 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
Who cannot join
- Use drugs
- Have an instable mental health
- Give their newborn infant for adoption
- Require surgery
- Have intraventricular haemorrhage (IVH) > grade 2
- Have congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Participation to Positioning (GP_Posit) Intervention for Mothers of Preterm Infants in the Neonatal Intensive Care Unit for Maternal Sensitivity and Infant's Neurodevelopment: Randomized Pilot Trial
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.
- Conditions
- Preterm Infant, Mothers, Parent-Child Relations, Child Development, Interaction, Mother-Infant
- Being tested
- GP_Posit
- Keywords
- Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP_PositOther
Also called Guided Participation intervention to positioning
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.
| Study group | Role | What they receive |
|---|---|---|
| GP_Posit | Experimental | Participants allocated to this arm will receive the GP_Posit intervention. Receives: Other: GP_Posit |
| Control | No intervention | Participants in the control arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to the protocole
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.
Measured: Through study completion, an average of 1 1/2 year.
Content analysis of acceptability questionnaires
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.
Measured: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Secondary outcomes (4)
Mother-Infant interaction
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.
Measured: When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
Parental beliefs about preterm infant and parental role
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.
Measured: 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)
General movement assessment (GMA)
General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.
Measured: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Electroencephalogram (EEG)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start20 Aug 2018
- Primary completion28 Feb 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréane Lavallée, St. Justine's Hospital
- Investigators
- Marilyn Aita, PhD, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677752
- Sponsor's protocol ID
- 2017-1540
- Acronym
- GP_Posit
- Status last verified
- May 2022
- First submitted
- 1 Aug 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28335806Lavallee 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.
PubMed 32509322
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Participation to Positioning (GP_Posit) Intervention for Mothers of Preterm Infants in the Neonatal Intensive Care Unit for Maternal Sensitivity and Infant's Neurodevelopment: Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT03677752
- Acronym / sponsor ID
- GP_Posit / 2017-1540
- Conditions
- Preterm Infant, Mothers, Parent-Child Relations, Child Development, Interaction, Mother-Infant
- Keywords
- Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 19 Sep 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP_Posit | Experimental | Other: GP_PositParticipants allocated to this arm will receive the GP_Posit intervention. |
| Control | No intervention | –Participants in the control arm will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understand, write and read French and/or English
- 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
Key exclusion criteria (6 listed)
- Use drugs
- Have an instable mental health
- Give their newborn infant for adoption
- Require surgery
- Have intraventricular haemorrhage (IVH) > grade 2
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 |
|---|---|---|
| GP_PositAlso: Guided Participation intervention to positioningMother-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 | GP_Posit |
Primary outcome
Compliance to the protocole
Time frame: 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
Time frame: 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.
4 secondary outcomes
Mother-Infant interaction
Time frame: When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
Parental beliefs about preterm infant and parental role
Time frame: 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)
General movement assessment (GMA)
Time frame: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Electroencephalogram (EEG)
Time frame: 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)
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 9 May 2022.
- Background: PubMed 28335806Lavallee 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.
- Derived from this study: PubMed 32509322Lavallee 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.
- 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.
Marilyn Aita, PhD study director
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP_Posit in people with Preterm Infant and Mothers, run by St. Justine's Hospital at 1 site in Canada.
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 4 inclusion and 6 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 9 May 2022. 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 Canada. 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?
Compliance to the protocole (time frame: Through study completion, an average of 1 1/2 year.). The study lists 2 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 NCT03677752, which also lists 2 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 9 May 2022.