FathersPERAM-QUALNCT02201433
Study on the Treatment of Children and Their Families in Services Related to Early Childhood
An observational study of Fathers and Premature Birth, run by University Hospital, Brest at 2 sites in France.
Trial summary
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units. There are few data concerning the fathers of preterm infants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fathers, Premature Birth
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2014to Jan 2019
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Part 1: caregivers and members of associations of preterm parents Part 2: fathers of preterm newborns, hospitalized in a neonatal intensive care unit Part 3: fathers who have experienced premature and caregivers of NICU who not participating in the first part
Who may be able to join
- Member of Association of Parents of premature children major (born before 37 weeks)
- Medical staff (doctors, nurses, pediatric nurses, social worker, ...) working in the NICU of the study.
- Signing of free and informed consent
- PART 2
- major fathers of child born before 37 weeks who survived to the early neonatal period (7days),
- French mother tongue,
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- Residing in the geographical area of Brest
- Signing of free and informed consent
- Inclusion between Day 7 and Day 30 after the birth of their child
- PART 3
- fathers who have experienced child born premature
- caregivers of NICU
- PART 1, 2 and 3 exclusion criteria:
- Person whose refuse to participate
- Persons unable to consent
- Persons whose monitoring is impossible
- minor
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units. There are few data concerning the fathers of preterm infants. However, the role of the father is identified in the literature as a key factor in the initiation and continuation of breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not identified but may be related to the father being in close and constant contact with the medical and paramedical staff. In fact, fathers are often first in contact with caregivers. They can be invested in the implementation of nursing care, skin to skin, as well as being asked to support the development of their child in the service and at home.
The aims of this study are to:
- Analyze the beliefs, social representations and the experience of the fathers of premature infants hospitalized in intensive care unit concerning breastfeeding.
- Analyze the factors facilitating and inhibiting the initiation and continuation of breastfeeding.
- Consider strategies of care and support that can be used for the families of premature infants and of children born at term.
- Explore the expectations of medical staff with regards to the management of children and families, their practices, identify the role attributed to the father.
- Initiate and facilitate reflexivity of medical and paramedical staff about their respective practices
Read the detailed description
The study will be conducted in three phases according to the methodology of qualitative research:
- The first for the preparation of interview guides and observation grids through the inclusion of 20 participants: caregivers and members of associations of preterm parents,
- The second part: maintenance by the inclusion of 40 fathers of children born preterm before 37 weeks and their partner if she wants.
- The third part will, as in any qualitative analysis, data validation with the inclusion of 20 participants: fathers who experienced this situation in the context of care and caregivers close to neonatal intensive unit care (NICU) are participants in the first phase. interview methods:
- 1 exploratory interview two hours on average with each part 1 and part 3 participants.
- 3-5 interviews per part 2 participant. Interviews are conduct with guideline constructed during the first part of the study. Interview will be conducted by a nurse and /or a psychologist
Data analysis:
Full transcript of the interviews. Partial treatment during the study to enrich the interview guide until data saturation. All data will be treated differently: Software-aided thematic treatment (NVivo) and textual processing with cross medical data and socio-demographic variables (Alceste).
Data Validation :
Part 3 of the study external validation. Literature validation
- Conditions
- Fathers, Premature Birth
- Keywords
- breastfeeding, fathers, preterm newborns, partner influence
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| medical staff and member of an association | members of medical staff and member of an association of parents of premature infants. This cohort is necessary to build protocol interview for part 2 of the study | |
| fathers | fathers of preterm newborns | |
| fathers or médical staff | This cohort is build for data validation. We will include fathers who have experienced this situation. Caregivers of NICU who are not participating in the first part |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviews
PERAM QUAL is a qualitative study, in accordance with the methodology of qualitative study, it is not possible to establish a quantitative criterion of judgment.
Full transcript of the interviews should permit the identification of factors that promote breastfeeding.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FathersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HELENE DENOUAL, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201433
- Sponsor's protocol ID
- PERAM-QUAL
- Acronym
- PERAM-QUAL
- Status last verified
- May 2019
- First submitted
- 9 Jul 2014
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study
- ClinicalTrials.gov ID
- NCT02201433
- Acronym / sponsor ID
- PERAM-QUAL / PERAM-QUAL
- Conditions
- Fathers, Premature Birth
- Keywords
- breastfeeding, fathers, preterm newborns, partner influence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 28 Jul 2014 (estimated)
- 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.
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units. There are few data concerning the fathers of preterm infants. However, the role of the father is identified in the literature as a key factor in the initiation and continuation of breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not identified but may be related to the father being in close and constant contact with the medical and paramedical staff. In fact, fathers are often first in contact with caregivers. They can be invested in the implementation of nursing care, skin to skin, as well as being asked to support the development of their child in the service and at home.
The aims of this study are to:
- Analyze the beliefs, social representations and the experience of the fathers of premature infants hospitalized in intensive care unit concerning breastfeeding.
- Analyze the factors facilitating and inhibiting the initiation and continuation of breastfeeding.
- Consider strategies of care and support that can be used for the families of premature infants and of children born at term.
- Explore the expectations of medical staff with regards to the management of children and families, their practices, identify the role attributed to the father.
- Initiate and facilitate reflexivity of medical and paramedical staff about their respective practices
Detailed description
The study will be conducted in three phases according to the methodology of qualitative research:
- The first for the preparation of interview guides and observation grids through the inclusion of 20 participants: caregivers and members of associations of preterm parents,
- The second part: maintenance by the inclusion of 40 fathers of children born preterm before 37 weeks and their partner if she wants.
- The third part will, as in any qualitative analysis, data validation with the inclusion of 20 participants: fathers who experienced this situation in the context of care and caregivers close to neonatal intensive unit care (NICU) are participants in the first phase. interview methods:
- 1 exploratory interview two hours on average with each part 1 and part 3 participants.
- 3-5 interviews per part 2 participant. Interviews are conduct with guideline constructed during the first part of the study. Interview will be conducted by a nurse and /or a psychologist
Data analysis:
Full transcript of the interviews. Partial treatment during the study to enrich the interview guide until data saturation. All data will be treated differently: Software-aided thematic treatment (NVivo) and textual processing with cross medical data and socio-demographic variables (Alceste).
Data Validation :
Part 3 of the study external validation. Literature validation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medical staff and member of an association | – | –members of medical staff and member of an association of parents of premature infants. This cohort is necessary to build protocol interview for part 2 of the study |
| fathers | – | –fathers of preterm newborns |
| fathers or médical staff | – | –This cohort is build for data validation. We will include fathers who have experienced this situation. Caregivers of NICU who are not participating in the first part |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Part 1: caregivers and members of associations of preterm parents Part 2: fathers of preterm newborns, hospitalized in a neonatal intensive care unit Part 3: fathers who have experienced premature and caregivers of NICU who not participating in the first part
Key inclusion criteria (17 listed)
- Member of Association of Parents of premature children major (born before 37 weeks)
- Medical staff (doctors, nurses, pediatric nurses, social worker, ...) working in the NICU of the study.
- Signing of free and informed consent
- PART 2
- major fathers of child born before 37 weeks who survived to the early neonatal period (7days),
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interviews
Time frame: Day 7
PERAM QUAL is a qualitative study, in accordance with the methodology of qualitative study, it is not possible to establish a quantitative criterion of judgment. Full transcript of the interviews should permit the identification of factors that promote breastfeeding.
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 29 May 2019.
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Perinatal Mental Health, Fathers
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Effectiveness of GEMPO E-Education on Fathers' Self-Efficacy and Ability in Newborn Care
Fathers' Self-Efficacy and Ability in Newborn Care
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Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
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Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction
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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.
HELENE DENOUAL principal investigator
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fathers and Premature Birth, run by University Hospital, Brest at 2 sites in France.
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 17 inclusion and 0 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Interviews (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2019.