Study on the Treatment of Children and Their Families in Services Related to Early Childhood

Premature Birth Clinical Trial

— PERAM-QUAL  

Official title:

Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201433
• Other study ID #: PERAM-QUAL
• Status: Completed
• Start date: July 2014
• Est. completion date: January 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

PART 1

Inclusion Criteria:

• 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

Inclusion Criteria:

• major fathers of child born before 37 weeks who survived to the early neonatal period (7days),

• French mother tongue,

• 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

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fathers
• Premature Birth

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	CH du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7