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Trial record 17 of 224 for:    Aldosterone

Aldosterone Resistance in Preterm Infants (PREMALDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01176162
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : April 30, 2014
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date July 6, 2010
First Posted Date August 5, 2010
Last Update Posted Date April 30, 2014
Study Start Date January 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2013)
urinary aldosterone [ Time Frame: during the first year of life ]
Determination of normal values of urinary aldosterone concentration in each group (24 first hours, day three, and at 1 and 3 months)
Original Primary Outcome Measures
 (submitted: August 4, 2010)
urinary aldosterone [ Time Frame: during the first year of life ]
Determination of normal values of urinary aldosterone concentration in each group (24 first hours, day three, and at 1,3, 6 and 12 months)
Change History Complete list of historical versions of study NCT01176162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 4, 2010)
  • plasma electrolytes concentrations [ Time Frame: first year of life ]
    Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.
  • urinary electrolytes concentrations [ Time Frame: first year of life ]
    Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.
  • hormonal measurements [ Time Frame: first year of life ]
    Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.
  • clinical parameters [ Time Frame: first year of life ]
    Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aldosterone Resistance in Preterm Infants
Official Title PREMALDO : Aldosterone Resistance in Preterm Infants : Assessment by a Non Invasive Measurement of Urinary Aldosterone
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.
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 of normal values of urinary aldosterone concentration in each group.

Secondary objectives:

Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.

Methodology : multicentric study, open study Two hundred-forty newborns will be included in order to constitute 4 groups of 60 children, classified according to their gestational age: < 28 GW, 28 - < 33 GW, 33- < 37 GW, > 37 GW.

Inclusion criteria: every newborn will be included, after written parental consent was obtained.

Study :

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. Aldosterone and renin concentrations will be measured in BICETRE Hospital laboratory. Plasma and urinary electrolyte concentrations will be measured in the Biochemistry department. DNA samples will also be gathered from umbilical cord blood for future genetic investigations (functional polymorphisms of the MR gene).

Perspectives This study will permit to assess the intensity of aldosterone resistance in full-term and preterm newborns, by a non invasive method. It should bring new insights into the mechanisms of hormonal regulation of sodium balance in preterm newborns and during the first year of life. Urinary aldosterone assessments may open new perspectives for therapeutic management of water and sodium waste in premature infants.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
  • 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
Sampling Method Non-Probability Sample
Study Population Every newborn without congenital malformation will be included, after written parental consent was obtained
Condition Newborn
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2013)
170
Original Estimated Enrollment
 (submitted: August 4, 2010)
240
Actual Study Completion Date December 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Weeks to 41 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01176162
Other Study ID Numbers P081211
B91017-20 ( Other Grant/Funding Number: Proper Authorithies : AFSSaPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Pascal BOILEAU, MD PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2014