Status:
COMPLETED
Aldosterone Resistance in Preterm Infants
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Newborn
Eligibility:
All Genders
24-41 years
Brief Summary
In the neonatal period, the human kidney is characterized by a functional immaturity responsible for an impaired ability to regulate water and sodium homeostasis, which is exacerbated by prematurity. ...
Detailed Description
Principal objective: To assess aldosterone resistance at birth by a non invasive measurement of urinary aldosterone, in order to evaluate its intensity as a function of gestational age. Determination...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Maternal
- Maternal age ≥ 18 and ≤ 45 years,
- Written parental consent
- Normal obstetrical ultrasounds
- Neonatal - Birth by vaginal delivery or cesarean section
- Exclusion criteria :
- Maternal
- Type 1 or type 2 diabetes,
- Adrenal or hypophyseal deficiency
- Treatment for arterial hypertension
- Neonatal
- Perinatal anoxia (defined by an Apgar score \< 5 at 5 min and pH \< 7,10 and lactacidemia \> 9 mmol/l at blood cord).
- Congenital malformation
- Chromosomic abnormalities
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01176162
Start Date
January 1 2010
End Date
December 1 2013
Last Update
April 30 2014
Active Locations (1)
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1
Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
Clamart, Île-de-France Region, France, 92140