L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01306227
First received: February 28, 2011
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.

The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.


Condition Intervention Phase
Hypothyroxinemia
Drug: L-Thyroxine
Drug: water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Neurodevelopmental outcome [ Time Frame: 2 years old ] [ Designated as safety issue: Yes ]
    Brunet-Lézine score


Secondary Outcome Measures:
  • Morbidity associated with management of newborns < 32 WG with hypothyroxinemia [ Time Frame: discharge, 1 year, 2 years ] [ Designated as safety issue: Yes ]
    • Death
    • Bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age)
    • Patent ductus arteriosus,
    • Shock requiring fluid loading or vasoactive treatments
    • Enterocolitis
    • Intraventricular hemorrhage
    • Retinopathy of prematurity
    • Deafness


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: water
Oral treatment with water for 6 weeks
Drug: water
Oral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day.
Experimental: L-Thyroxine
Oral treatment with L-Thyroxine for 6 weeks
Drug: L-Thyroxine
Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.

Detailed Description:

Preterm newborns <32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of life. THOP is defined by thyroid-stimulating hormone (TSH) < 20 mIU/L and FT4 < 0.80 ng/dL. After obtaining written consent from the parents, preterm newborns <32 WG with THOP will be included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed 2 weeks after stopping treatment.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age < 32 WG
  • FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL
  • TSH (5, 6 or 7 days of life) < 20 mIU/L
  • Written consent from the parents

Exclusion Criteria:

  • Maternal thyroid disease
  • FT4 (5, 6 or 7 days of life) > 0.8 ng/dL
  • TSH (5, 6 or 7 days of life) > 20 mIU/L
  • Grade III or IV intracerebral hemorrhage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306227

Contacts
Contact: Pierre Tourneux, MD +33 3 22 66 82 86 tourneux.pierre@chu-amiens.fr
Contact: Bertrand Labattu +33 3 22 66 80 63 labattu.bertrand@chu-amiens.fr

Locations
France
Caen University Hospital Not yet recruiting
Caen, Basse normandie, France, 14033
Contact: Bernard Guillois, PhD    +33 2 31 27 25 64    guillois-b@chu-caen.fr   
Principal Investigator: Bernard Guillois, PhD         
Lens Hospital Not yet recruiting
Lens, Nord- Pas de calais, France, 62307
Contact: Serge Klosowski, MD    +33 3 21 69 11 39    sklosowski@ch-lens.fr   
Principal Investigator: Serge Klosowski, MD         
Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Pierre Tourneux, MD    +33 3 22 66 82 86    tourneux.pierre@chu-amiens.fr   
Contact: Bertrand Labattu    +33 3 22 66 80 63    labattu.bertrand@chu-amiens.fr   
Principal Investigator: Pierre Tourneux, MD         
Sub-Investigator: Cecile Fontaine, MD         
Sub-Investigator: Ghida Ramadan-Ghostine, MD         
Sub-Investigator: Helene Bony, MD         
Sub-Investigator: Bernard Boudailliez, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Pierre Tourneux, MD Amiens University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01306227     History of Changes
Other Study ID Numbers: PHRC IR07 - Dr TOURNEUX
Study First Received: February 28, 2011
Last Updated: September 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Infant, newborn
Infant, preterm
Thyroid
Outcome
Newborns less than 32 weeks of gestation
TSH < 20 mIU/L and a FT4 < 0.80 ng/dL

ClinicalTrials.gov processed this record on September 16, 2014