Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04555915 |
| Other study ID # |
GMA Version 1.2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Medical University of Graz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as
secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any
differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected
age.
Description:
OBJECTIVE In course of the SafeBoosC III trial, we would like to analyse routinely performed
GMA as as secondary outcome parameter in an ancillary observational study.
First aim is to analyse in surviving neonates included into the SafeboosC III trial any
differences between the experimental group group and control group in Global-GMA at term age.
Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected
age.
HYPOTHESES We hypothesise that the surviving preterm neonates in the experimental group of
the SafeBoosC III trial show better results in Global-GMA at term age compared to surviving
neonates in the control group.
Furthermore, we hypothesise that the surviving preterm neonates in the experimental group of
the SafeBoosC III trial show better results in GMOS at term age and in GMA if available at
9-16 weeks corrected age.
METHODS Trial design It will be a pilot observational ancillary study to the SafeBoosC III
trial.
Eligibility Preterm neonates included in SafeBoosC III trial are eligible to be included in
this ancillary study. Neonates will be included, in whom GM assessment is performed routinely
at corrected term age or before discharge and optionally at a corrected age between 9 to 16
weeks. The infants are recorded according to routine after feeding, during periods of active
wakefulness and lying in a supine position for 10-20 minutes. To evaluate the GMA visual
Prechtl Gestalt perception are used. Because of the routine use in GMA, handling should reach
the quality parameters, necessary for an optimal interpretation of these results.
Outcome measures Primary outcome measure for this ancillary observational study will be
Global-GMA at term age Secondary outcome measure for this ancillary observational study will
be GMOS at term age and if available GMA at a corrected age between 9 to 16 weeks.
Blinding Interpretation of Global-GMA and GMOS will be performed by analysing
pseudo-anonymised video-recordings by persons trained in GMA and not involved in the care of
the neonates.
GMA Data Global GMA will be classified as normal and abnormal (poor repertoire, chaotic,
cramped synchronised at term age/absent fidgety movements at corrected age of 9-16 weeks).
GMOS will be scored from zero to 42.
Data managing plan Demographic data will be handled according the data managing plan of the
SafeboosC III protocol in its latest version.
GMA and GMOS data will be anonymised at each centre participating in this ancillary study
with the local patient ID used in the SafeboosC III trial and handled according to local
guidelines. Local statistical analyses will be performed in each participating centre in this
ancillary study and just the results of these statistical analyses will be transferred to
Medical University of Graz, Graz, Austria for overall/meta-analyses.
Statistical analyses Baseline characteristics of neonates will be given as mean and standard
deviation or median and interquartile range for continuous data and as numbers and
percentages for categorical data. Comparison of baseline characteristics will be done by
using t-Test or Mann Whitney U-test for continuous data and Chi-square test or Fisher's exact
test for categorical data. To answer the primary hypothesis whether global GMA differ between
neonates of the control group and neonates of the intervention group OR will be calculated
within each center. To analyze the secondary outcome measure GOMS a modified version of
Agresti's (1980) generalized odds ratio (genOR), which accounts for ties, will be calculated
within each center.
genOR=(Prob(Y_1Y_2)) Since data are collected in the same study and
therefore the study designs are the same, we assume the treatment effect to be the same and
differences in the results between centers are due to a random error. As a consequence data
will be combined using fixed effect models. Overall OR for the global GMA and the GOMS will
be calculated and Forest plots drawn.
