• Users Online: 149
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
Year : 2018  |  Volume : 3  |  Issue : 2  |  Page : 74-80

Does early injection of mouse nerve growth factor affect motor and cognitive abilities in high-risk infants? study protocol for a randomized parallel-controlled trial

Department of Developmental Behavioral Pediatrics, The First Hospital of Jilin University, Changchun, Jilin Province, China

Correspondence Address:
Fei-Yong Jia
Department of Developmental Behavioral Pediatrics, The First Hospital of Jilin University, Changchun, Jilin Province
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2542-3932.232080

Rights and Permissions

Background and objectives: Newborns with perinatal risk factors and abnormal general motor quality assessment are at high risk of developing cerebral palsy. The treatment is earlier, the prognosis is better. This trial will investigate whether, combined with conventional early interventional therapy, the use of mouse nerve growth factor in high-risk infants can improve their motor and cognitive abilities. Design: This is a prospective, single-center, randomized, parallel, controlled, clinical trial. Methods: This trial will be conducted in the Department of Developmental Behavioral Pediatrics, the First Hospital of Jilin University, China. One hundred high-risk infants meeting the inclusion criteria will be recruited and randomized into control and treatment groups. Only participants in the treatment group will undergo the early treatment of mouse nerve growth factor via gluteus maximus injections, 20 μg per dose, once a day, 10 consecutive days per month. The treatment will last for 6 months. Both groups will receive standard early intervention therapies. Outcome measures: The primary outcome measure is the incidence of the developmental disorders cerebral palsy and non-cerebral palsy at the actual age or corrected age of 12 months. The secondary outcome measures are Gesell Developmental Schedule scores at the actual age or corrected age of 12 months, Gross Motor Function Measure score at 6 and 12 months of treatment, and adverse events during the trial. Discussion: If treatment with mouse nerve growth factor is found to be safe and effective for the high-risk infants, new options for the early-stage clinical treatment for such infants may be developed. Ethics and dissemination: This trial has been approved by the Ethics Committee of First Hospital of Jilin University of China [approval number: 2017 (2017-290)]. This trial was designed in August 2017. Ethics approval was done in October 2017. This trial was registered in November 2017. The recruitment of subjects began in December 2017. Data analysis will be finished in December 2021. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012774). Protocol version (2.0).

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded140    
    Comments [Add]    
    Cited by others 1    

Recommend this journal