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

NCT02201433 | Completed DMC

• 1 other identifier: PERAM-QUAL
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 2

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

Conditions

Fathers; Premature Birth

Keywords

breastfeeding; fathers; preterm newborns; partner influence

Outcome Measures

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.

  Day 7

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,
• Residing in the geographical area of Brest
• Signing of free and informed consent
• PART 3
• fathers who have experienced child born premature
• caregivers of NICU

You may not qualify if:

• Person whose refuse to participate
• Persons unable to consent
• Persons whose monitoring is impossible
• minor

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU de Brest

Brest, 29200, France

Location

CH du Mans

Le Mans, France

Location

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• HELENE DENOUAL

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 28, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

FR (2)