Text Size

Aldosterone Resistance in Preterm Infants (PREMALDO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01176162
First received: July 6, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Newborn

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PREMALDO : Aldosterone Resistance in Preterm Infants : Assessment by a Non Invasive Measurement of Urinary Aldosterone

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • urinary aldosterone [ Time Frame: during the first year of life ] [ Designated as safety issue: No ]
    Determination of normal values of urinary aldosterone concentration in each group (24 first hours, day three, and at 1 and 3 months)


Secondary Outcome Measures:
  • plasma electrolytes concentrations [ Time Frame: first year of life ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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

Enrollment: 170
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 41 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176162

Locations
France
Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
Clamart, Ile de France, France, 92140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Pascal BOILEAU, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01176162     History of Changes
Other Study ID Numbers: P081211, B91017-20
Study First Received: July 6, 2010
Last Updated: April 3, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Non Invasive measurement
Preterm infants
Aldosterone resistance

ClinicalTrials.gov processed this record on June 17, 2013