Fludrocortisone in great premature babies.

Phase 1

• Conditions: Great prematurity; MedDRA version: 19.0Level: LLTClassification code 10053593Term: Premature baby 26 to 32 weeksSystem Organ Class: 100000004868; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2016-000649-30-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-20
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

- Very premature newborns defined by a gestational age <32 weeks of amenorrhea and >= 26 weeks of amenorrhea
- Eutrophic: weight between 10th and 90th percentile on the French reference curves AUDIPOG
- Absence of defects or chromosomal abnormality identified
- Lack of adrenal disease, pituitary gonadal or for prenatal diagnosis
- Lack of participation in another research protocol
- Children born and hospitalized in the four neonatology services participating in the study
- Informed consent of the holders of the exercise of parental authority
Are the trial subjects under 18? yes
Number of subjects for this age range: 66
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Maternal treatment prior to pregnancy: systemic or inhaled corticosteroids, hormone therapy for adrenal or pituitary insufficiency, antihypertensive treatment (calcium channel blockers, beta blockers, angiotensin)
- Lack or incomplete treatment of antenatal glucocorticoids (betamethasone)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified