Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01306227
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date  ICMJE February 28, 2011
First Posted Date  ICMJE March 1, 2011
Last Update Posted Date August 10, 2018
Actual Study Start Date  ICMJE September 1, 2006
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
Neurodevelopmental outcome [ Time Frame: 2 years old ]
Brunet-Lézine score
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01306227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
Morbidity associated with management of newborns < 32 WG with hypothyroxinemia [ Time Frame: discharge, 1 year, 2 years ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
Official Title  ICMJE L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypothyroxinemia
Intervention  ICMJE
  • Drug: L-Thyroxine
    Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: water
    Oral treatment with water for 6 weeks
    Intervention: Drug: water
  • Experimental: L-Thyroxine
    Oral treatment with L-Thyroxine for 6 weeks
    Intervention: Drug: L-Thyroxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2011)
200
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306227
Other Study ID Numbers  ICMJE PHRCIR07-DR-TOURNEUX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre Tourneux, MD Amiens University Hospital
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP