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CompletedNCT02201433PERAM-QUALUpdated May 29, 2019

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

An observational study in Fathers and Premature Birth, sponsored by University Hospital, Brest. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years and older
Sex
All
01

Study 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
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

02

Conditions studied

  • Fathers
  • Premature Birth

Keywords

  • breastfeeding
  • fathers
  • preterm newborns
  • partner influence
03

In context

Premature Birth

2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's enrollment of 74 is below the median of 115 across 798 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 600 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 7

07

Study locations

2 sites
  • CHRU de Brest
    Brest, 29200, France
  • CH du Mans
    Le Mans, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02201433
Responsible party
Sponsor
First posted
Jul 28, 2014
Start date
Jul 2014
Primary completion
Jan 2019
Completion
Jan 2019
Last update
May 29, 2019

Study contacts

HELENE DENOUAL
principal investigator · University Hospital, Brest

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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