Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 8:12 PM
Study NCT ID:
NCT02201433
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Treatment of Children and Their Families in Services Related to Early Childhood
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERAM-QUAL
Brief 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. 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
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: