Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
40

Summary

Conditions
Premature Birth
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 2832 years
Gender
Both males and females

Description

Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withd...

Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.

Tracking Information

NCT #
NCT02024854
Collaborators
  • St. Olavs Hospital
  • Drammen sykehus
  • Sorlandet Hospital HF
  • IWK Health Centre
Investigators
Study Director: Håkon Bergseng, md phd Norwegian University of Science and Technology