RECRUITING

Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Official Title

A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment

Quick Facts

Study Start:2023-12-10
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06103513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, aged 5-15 years
  4. 4. In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
  5. 5. Ability to take subcutaneous GH injections nightly
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jennifer Apsan, MD
CONTACT
516-472-3750
japsan@northwell.edu
Rashida Talib, MPH
CONTACT
516-472-3631
rtalib@northwell.edu

Principal Investigator

Benjamin U. Nwosu, MD
PRINCIPAL_INVESTIGATOR
NORTHWELL HEALTH, INC.

Study Locations (Sites)

Northwell Health
New York, New York, 11042
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Benjamin U. Nwosu, MD, PRINCIPAL_INVESTIGATOR, NORTHWELL HEALTH, INC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-10
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2023-12-10
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

  • Growth Hormone

Additional Relevant MeSH Terms

  • Growth Disorders
  • Growth Failure
  • Growth Hormone Treatment
  • Growth