Great prematurity MedDRA version: 19.0 Level: LLT Classification code 10053593 Term: Premature baby 26 to 32 weeks System Organ Class: 100000004868
Conditions
Interventions
Product Name: Fludrocortisone
Pharmaceutical Form: Tablet
INN or Proposed INN: Fludrocortisone
Other descriptive name: Fludrocortisone
Concentration unit: µg microgram(s)
Concentration type: equal
Con
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Very premature newborns defined by a gestational age = 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of supplementation by Fludrocortisone (mineralocorticoid agonist) versus placebo in H24 (24 hours of life corresponding to D1) D8 (8th day of life) to D3 on sodium excretion in children born great premature (before 32 weeks of amenorrhea).;Secondary Objective: To evaluate the effect and safety of substitution Fludrocortisone of H24 to D8 versus placebo in very premature babies: - Short term (D1 to D15) on the electrolyte balance and renal mineralocorticoid action level; blood pressure and weight; the number of blood tests performed in this period - In the medium term up to 36 weeks post-conceptional on blood pressure, weight, mineralocorticoid function, major morbidity indicators of extremely premature - Long-term (up to M12) on blood pressure, weight, mineralocorticoid action kidneys - PK of Fludrocortisone in very premature infants during the first 8 days of life - Validation of the urinary ratio: Aldosterone / Na at D0 as a predictive index sodées losses in population control and as a predictive index for renal mineralocorticoid sensitivity in the treated population D3 life.;Primary end point(s): Main: measuring the Na / urinary creatinine ratio at D3 (indicating kidney action Fludrocortisone and lower sodées losses) on the urine collection pad, placed in the layer of the newborn.;Timepoint(s) of evaluation of this end point: Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): secondary: 1 Efficiency: -quantification of sodium urinary losses (Na / creat urinary ratio) to D1, D3, D5, D8, D10 and D15 -quantification of fluid intake (ml / kg / day) and sodium intake (mEq / kg / d) of D1 to D8, D10 and D15 -rated serum sodium and potassium levels in D1, D3, D8 and D15 -measure plasma renin on D1, D3, D8 and D15 - quantification of the number of blood tests performed in this period -rated complications occurred up to 36 WPC corrected age, based on clinical and exam results achieved under the care: opersistance of ductus arteriosus at echocardiography between D2 and D5 and between D7 and D15 ointraventricular hemorrhage at trans-fontanel ultrasound between D2 and D5 and between D7 and D15 and at 36 WPC obronchopulmonary dysplasy evaluated by a need for FiO2> 21% at D28 and severity assessed by the Walsh test conducted at 36 WPC oduration in days of intubation invasive and non-invasive oulcerous and necrotizing enterocolitis -Persistance of ductus arteriosus at echocardiography between D2 and D5 and between D7 and D15 -Presence of intraventricular hemorrhage in the trans-fontanel ultrasound (ETF) between D2 and D5, and between D7 and D15, and at the age of 36 WPC -Duration In days of invasive and non-invasive intubation -Need in FiO2> 21% at D28 and Walsh test made at 36 WPC. 2 Tolerance: -Arterial tension and weight gain in newborns from D1 to D8, at D10, at D15 and at the age of 36 WPC. -Arterial tension, weight and urinary dosage of aldosterone and cortisol in M1, M3, M6 and actual age M12 (non-invasive measurement of urine collection by compress) 3 Pharmacokinetics: -Settings pharmacokinetics of Fludrocortisone by plasma measurement at D1 and D3 or at D8 (EDTA tube, same tube as for renin, which will be done at the same time at D1, D3 or D8), total volume <= 0.5 ml): oat D1 after the first dose of the experimental treatment (2 samples from umbilical catheter, the first between 0 and 3 hours after administration of t | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed