Trial Outcomes & Findings for Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin (NCT NCT01207778)
NCT ID: NCT01207778
Last Updated: 2023-08-04
Results Overview
Infants who received ESAs during their initial hospitalization will perform significantly better on measures of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) full scale IQ, performance IQ, verbal IQ, and executive function. Scores are standardized, 100 is an average score with a standard deviation of 15. Higher scores are better. Test scores range from 41 to 160.
Recruitment status
COMPLETED
Target enrollment
77 participants
Primary outcome timeframe
42-48 months and 66-72 months
Results posted on
2023-08-04
Participant Flow
Participant milestones
| Measure |
Preterm ESA Recipients
infants 500-1250 grams who received erythropoietin (400 units/kg 3x/week) or darbepoetin (10 micrograms/kg 1x/week), from the first week of life through 35 weeks corrected gestation
|
Term Controls
Term infants with normal delivery
|
Preterm Controls
infants 500-1250 grams who received placebo (sham doing) three times a week from the first week of life through 35 weeks corrected gestation
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
24
|
14
|
|
Overall Study
COMPLETED
|
39
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Preterm ESA Recipients
infants 500-1250 grams who received erythropoietin (400 units/kg 3x/week) or darbepoetin (10 micrograms/kg 1x/week), from the first week of life through 35 weeks corrected gestation
|
Term Controls
Term infants with normal delivery
|
Preterm Controls
infants 500-1250 grams who received placebo (sham doing) three times a week from the first week of life through 35 weeks corrected gestation
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
3
|
Baseline Characteristics
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Baseline characteristics by cohort
| Measure |
Preterm ESA Recipients
n=39 Participants
children 3.5-4 years of age who received ESAs during hospitalization
|
Preterm Controls
n=14 Participants
children 3.5-4 years of age who received placebo during hospitalization
|
Term Controls
n=24 Participants
healthy children 3.5-4 years of age born term
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
47 months
n=5 Participants
|
48.5 months
n=7 Participants
|
45.5 months
n=5 Participants
|
47 months
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
77 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 42-48 months and 66-72 monthsPopulation: Subjects were seen around 4 years and 6 years of age. Initial numbers of subjects seen at 4 years were: Placebo group (14), ESA (39), Term (24). Numbers of subjects ween at 6 years were: Placebo (11), ESA (39), Term (21).
Infants who received ESAs during their initial hospitalization will perform significantly better on measures of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) full scale IQ, performance IQ, verbal IQ, and executive function. Scores are standardized, 100 is an average score with a standard deviation of 15. Higher scores are better. Test scores range from 41 to 160.
Outcome measures
| Measure |
Placebo Group
n=14 Participants
3.5-4 year olds who received placebo during hospitalization
|
ESA Recipients
n=39 Participants
subjects received ESAs during their initial hospitalization
|
Term Controls
n=24 Participants
children who were born healthy at term
|
|---|---|---|---|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
full scale IQ at 4 years
|
79 standardized score on a scale
Standard Deviation 18
|
91 standardized score on a scale
Standard Deviation 17
|
103 standardized score on a scale
Standard Deviation 13
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
verbal IQ at 4 years
|
83 standardized score on a scale
Standard Deviation 17
|
92 standardized score on a scale
Standard Deviation 18
|
101 standardized score on a scale
Standard Deviation 15
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
performance IQ at 4 years
|
79 standardized score on a scale
Standard Deviation 19
|
93 standardized score on a scale
Standard Deviation 17
|
104 standardized score on a scale
Standard Deviation 11
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
executive function
|
91 standardized score on a scale
Standard Deviation 13
|
100 standardized score on a scale
Standard Deviation 12
|
105 standardized score on a scale
Standard Deviation 8
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
full scale IQ at 6 years
|
82 standardized score on a scale
Standard Deviation 17
|
94 standardized score on a scale
Standard Deviation 19
|
100 standardized score on a scale
Standard Deviation 14
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
verbal IQ at 6 years
|
86 standardized score on a scale
Standard Deviation 17
|
93 standardized score on a scale
Standard Deviation 19
|
98 standardized score on a scale
Standard Deviation 15
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
performance IQ at 6 years
|
82 standardized score on a scale
Standard Deviation 15
|
97 standardized score on a scale
Standard Deviation 16
|
102 standardized score on a scale
Standard Deviation 14
|
|
Full Scale IQ, Performance IQ, Verbal IQ, Executive Function
executive function at 6 years
|
92 standardized score on a scale
Standard Deviation 15
|
99 standardized score on a scale
Standard Deviation 12
|
107 standardized score on a scale
Standard Deviation 11
|
Adverse Events
ESA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Term Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place