Neonatal Clinical Trials
Neonatal Clinical Trials 1
Angela K. Tyson, DO (she/her/hers)
Assistant Professor of Pediatrics, Neonatology Division
Golisano Children's Hospital at The University of Rochester Medical Center
Pittsford, New York, United States
This was a single center, blinded randomized study comparing OMM and SOC in infants < 34 weeks gestational age (GA).
Intervention: Subjects < 28 weeks GA at birth received standard NICU care until 28 weeks corrected GA (cGA). Once >28 weeks cGA and study criteria met, randomization occurred 1:1 in 4 gestational age strata. Infants in the OMM (treatment) group then received weekly OMM until 36 weeks’ cGA; the control group received only SOC throughout. All parents and clinical care team members were blinded to group assignment, with exception of the primary investigator who performed OMM. At 36-37 weeks CGA, the TIMP was performed by a certified occupational therapist blinded to group assignment. The primary investigator was blinded from TIMP scores until the end of the study.
Analysis: TIMP scores and LOS were compared between groups using t test and Wilcoxon Rank Sum test; multiple linear regression was used to evaluate the treatment effect after controlling for covariates.