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NCT Number: NCT02201433

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

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

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Key information

Conditions

Fathers Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest, Brest, France

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PERAM-QUAL

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2014
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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