Partial Mineralocorticoid Deficiency Clinical Trial
— MINIPREMOfficial title:
Impact of the Administration of Fludrocortisone on Fluid and Electrolyte Balance in Very Premature Infants: Pilot Study
| Verified date | February 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway (renin-angiotensin-aldosterone system acting on the renal tubule). However, the neonatal period in humans is characterized by a reduced ability of the kidney to ensure normal functions of urine concentration and maintenance of sodium and water balance. This renal functional immaturity, is associated in the very premature infants (VPT) (born <32 weeks of amenorrhea (SA)) to an immaturity of the adrenal responsible for a default of aldosterone biosynthesis . This relative aldosterone deficiency induces difficulties for VPT to adapt to extra-uterine life when maintaining a positive sodium balance is essential for postnatal growth. The improvement of perinatal care (antenatal corticosteroids maturation, ventilation techniques and use of surfactant) have increased the survival of these children . Nevertheless, extreme prematurity (less than 32 weeks), which concerns nearly 2% of live births in France, remains associated with neurodevelopmental sequelae in nearly 40% of children at 5 years . Secondary hydroelectrolytic disorders with transient mineralocorticoid adrenal insufficiency is probably one of the factors responsible of these neurological deleterious outcomes as well as the occurrence of other complications (bronchopulmonary dysplasia, enterocolitis necrotizing) of extreme prematurity. Indeed, aside from the administration of antenatal steroids to induce maturation, the prevention of postnatal dehydration reduces the risk of intracranial hemorrhage in that population. However, high fluid intake are associated with an increased incidence of patent ductus arteriosus, of bronchopulmonary dysplasia and necrotizing enterocolitis. This necessitates the evaluation of preventive measures to avoid such fluid and electrolyte imbalances by a pharmacological approach based on mineralocorticoid administration in very premature infants, due to the relative aldosterone deficiency identified in this population.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | September 8, 2020 |
| Est. primary completion date | September 8, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 26 Weeks to 32 Weeks |
| Eligibility | Inclusion Criteria: - Very premature newborns defined by a gestational age <32 and = 26 gestational weeks - Eutrophic: birth weight between the 10th and 90th percentile of the French reference curves - Absence of malformations or chromosomal abnormality identified - Lack of adrenal, pituitary or gonadal diseases diagnosed prior birth - Lack of participation in another research protocol - "Inborn": born and hospitalized in the four neonatology departments participating in the study - Informed consent of the holders of parental authority 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Robert Debré | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urinary sodium loss evaluated by the urinary ratio Na / creatinine | Measurement of Na / urinary creatinine ratio at day 3 (evaluating the efficacity of Fludrocortisone action on the kidney by lowering sodium losses, that are very high in very premature infants) by collection of a urinary spot collected on a gauze compress, placed in the diaper of the newborn. | day 3 (when urinary sodium losses are at their highest in very premature infants) | |
| Secondary | Urinary sodium loss evaluated by the urinary ratio Na / creatinine | Measurement of Na / urinary creatinine ratio at day 1, 5, 8, 10 and 15 (evaluating the efficacity of Fludrocortisone action on the kidney by lowering sodium losses, that are very high in very premature infants) by collection of a urinary spot collected on a gauze compress, placed in the diaper of the newborn. | day1, day5, day8, day10 and day15 | |
| Secondary | urinary sodium and potassium concentrations | day1,day3, day5, day8, day10 and day15 | ||
| Secondary | plasma sodium and potassium concentrations | day1, day3, day8 et day15 | ||
| Secondary | plasma renin concentrations | day1, day3, day8 et day15 | ||
| Secondary | Number of blood tests | day1,day3, day5, day8, day10 and day15 | ||
| Secondary | Neonatal complications | up to 36 post-conceptional weeks (PCW) | ||
| Secondary | Patent ductus arteriosus (diagnosed by ultrasound) | Between day2 and day5 and between day7 and day15 | ||
| Secondary | Presence of intraventricular hemorrhage (diagnosed by ultrasound) | between day2 and day5, and between day7 and day15, and at the age of 36 PCW | ||
| Secondary | Oxygen inspired fraction (FiO2) | At Day 28 and 36 PCW | ||
| Secondary | Blood pressure | From day1 to day8, at day10, at day15, at one month, three month, six month, twelve month and at 36 PCW | ||
| Secondary | urinary dosage of aldosterone and cortisol | At one month, three month, six month and twelve month. | ||
| Secondary | urinary index (Aldosterone/Nau) | day3, day8 and day15 | ||
| Secondary | number of days of invasive and non invasive ventilation | At Day 28 and 36 PCW | ||
| Secondary | weight newborns | from day1 to day 8, at day 10 and day 15and at 36 PCW |