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

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).