Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03394443
Other study ID # P/2017/347
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2017
Last updated January 8, 2018
Start date December 28, 2017
Est. completion date April 2018

Study information

Verified date January 2018
Source Centre Hospitalier Universitaire de Besancon
Contact NAJID Hana
Phone 0033381219163
Email hana.najid@hotmail.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.


Description:

- From parents collected during semi-structured interviews.

- To highlight the social, environmental and economic difficulties that parents have encountered in the context of the premature birth of their child (before birth, during hospitalization and return home).

- Determine the possible help they need in the psychosocial and environmental field.

- Difficulties of the parents we expected:

- Pre-existing child birth: poor socio-economic environment, unstable social, family and / or occupational status, poorly followed pregnancy, etc.

- After the birth: professional break-up, custody of other children of the siblings, balance of the couple, financial loss, isolation, transportation problems to get to the hospital, etc.

- Needs we expected :

- Before birth: measures to prevent prematurity, social and/or psychological support, information, etc.

- After the birth: support of the entourage, interview with a social worker, help to come in hospital, help to live near the hospital, parental leave, project and long-term support, doctor referred, relationship with professionals in ambulatory (psychologist, Infant and Maternal Protection ...), preparation of the arrival of the child at home +/- home improvement, etc.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 37 Weeks
Eligibility Inclusion Criteria:

- Parents (father or mother ) of a premature new-born baby (< 37 SA) hospitalised in Besancon University Hospital at birth.

Exclusion Criteria:

- Parents < 18 years old

- Refusing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Semi-structured interviews
Semi-structured interviews of the parents of preterm infants. 3 weeks after their child has left hospital. They will be made either at the University Hospital of Besançon. They will take place in a dedicated hospital ward to ensure the confidentiality of the statements made between the investigator and the parent. They will follow a predefined questionnaire. They will be fully recorded on a dictaphone with note taking during the interview by the investigator and will be transcribed in writing anonymously and confidentially on Word. The content of the interviews will be analyzed: As a first step, it will be a vertical analysis of the thematization of each interview Then, in a second step, a transversal analysis between the contents of the different interviews.

Locations

Country Name City State
France CHU de Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Social, environmental and economic difficulties encountered by parents Qualitative analysis of semi-structured interviews Month 1
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04021654 - What is the Future of Vulnerable New-borns