NCT01176162

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. This altered sodium handling could be related to a partial renal aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The investigators have analyzed MR expression throughout human and mouse renal development, and the investigators found a weak MR expression at birth. The investigators have conducted a pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance. This study also highlighted that urinary aldosterone is the best index to accurately assess aldosterone sensitivity at birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

3.4 years

First QC Date

July 6, 2010

Last Update Submit

April 28, 2014

Conditions

Newborn

Keywords

Non Invasive measurementPreterm infantsAldosterone resistance

Outcome Measures

Primary Outcomes (1)

  • urinary aldosterone

    Determination of normal values of urinary aldosterone concentration in each group (24 first hours, day three, and at 1 and 3 months)

    during the first year of life

Secondary Outcomes (4)

  • plasma electrolytes concentrations

    first year of life

  • urinary electrolytes concentrations

    first year of life

  • hormonal measurements

    first year of life

  • clinical parameters

    first year of life

Study Arms (4)

Group "< 28"

• Gestational Age \< 28 weeks

Group "28 - < 33"

• Gestational Age : 28 - \< 33 weeks

Group "33- < 37"

Gestational Age : 33- \< 37 weeks

Group "> 37"

Gestational Age \> 37 weeks

Eligibility Criteria

Age24 Weeks - 41 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Every newborn without congenital malformation will be included, after written parental consent was obtained

You may qualify if:

  • Maternal
  • Maternal age ≥ 18 and ≤ 45 years,
  • Written parental consent
  • Normal obstetrical ultrasounds
  • Neonatal - Birth by vaginal delivery or cesarean section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital

Clamart, Île-de-France Region, 92140, France

Location

Related Publications (2)

  • Martinerie L, Viengchareun S, Delezoide AL, Jaubert F, Sinico M, Prevot S, Boileau P, Meduri G, Lombes M. Low renal mineralocorticoid receptor expression at birth contributes to partial aldosterone resistance in neonates. Endocrinology. 2009 Sep;150(9):4414-24. doi: 10.1210/en.2008-1498. Epub 2009 May 28.

    PMID: 19477942BACKGROUND

  • Martinerie L, Pussard E, Yousef N, Cosson C, Lema I, Husseini K, Mur S, Lombes M, Boileau P. Aldosterone-Signaling Defect Exacerbates Sodium Wasting in Very Preterm Neonates: The Premaldo Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4074-81. doi: 10.1210/jc.2015-2272. Epub 2015 Sep 8.

    PMID: 26348350DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Urinary samples will be collected onto a gauze compress, during the first 24 hours of life, at day three, and at 1, 3, 6 and 12 months. * A blood sample will be obtained from systematic umbilical cord blood collection at birth and during the Guthrie test at day three

Study Officials

  • Pascal BOILEAU, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

August 5, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

FR(1)