Trial Outcomes & Findings for Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) (NCT NCT01913340)
NCT ID: NCT01913340
Last Updated: 2020-07-13
Results Overview
The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Erythropoietin
1000 U/kg/dose x 5 doses
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Erythropoietin
1000 U/kg/dose x 5 doses
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
missing data from 2 placebo subjects
Baseline characteristics by cohort
| Measure |
Erythropoietin
n=24 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=26 Participants
Normal saline: placebo: NS IV x 5 doses
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age at randomization (hours)
|
13.3 hours
STANDARD_DEVIATION 6.1 • n=24 Participants • missing data from 2 placebo subjects
|
14.6 hours
STANDARD_DEVIATION 6.1 • n=24 Participants • missing data from 2 placebo subjects
|
13.9 hours
STANDARD_DEVIATION 6.1 • n=48 Participants • missing data from 2 placebo subjects
|
|
Age at 1st study drug (hours)
|
15.6 hours
STANDARD_DEVIATION 5.7 • n=24 Participants
|
17.2 hours
STANDARD_DEVIATION 6.1 • n=26 Participants
|
16.5 hours
STANDARD_DEVIATION 5.9 • n=50 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 7.2 • n=24 Participants
|
29.7 years
STANDARD_DEVIATION 6.6 • n=26 Participants
|
29.5 years
STANDARD_DEVIATION 6.8 • n=50 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants
|
10 Participants
n=26 Participants
|
24 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
16 Participants
n=26 Participants
|
26 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=24 Participants • Maternal Hispanic ethnicity provided
|
6 Participants
n=26 Participants • Maternal Hispanic ethnicity provided
|
11 Participants
n=50 Participants • Maternal Hispanic ethnicity provided
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=24 Participants • Maternal Hispanic ethnicity provided
|
20 Participants
n=26 Participants • Maternal Hispanic ethnicity provided
|
39 Participants
n=50 Participants • Maternal Hispanic ethnicity provided
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants • Maternal Hispanic ethnicity provided
|
0 Participants
n=26 Participants • Maternal Hispanic ethnicity provided
|
0 Participants
n=50 Participants • Maternal Hispanic ethnicity provided
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants • Maternal race provided
|
0 Participants
n=26 Participants • Maternal race provided
|
0 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants • Maternal race provided
|
1 Participants
n=26 Participants • Maternal race provided
|
3 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Maternal race provided
|
0 Participants
n=26 Participants • Maternal race provided
|
0 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=24 Participants • Maternal race provided
|
4 Participants
n=26 Participants • Maternal race provided
|
11 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
White
|
14 Participants
n=24 Participants • Maternal race provided
|
18 Participants
n=26 Participants • Maternal race provided
|
32 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants • Maternal race provided
|
0 Participants
n=26 Participants • Maternal race provided
|
0 Participants
n=50 Participants • Maternal race provided
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants • Maternal race provided
|
3 Participants
n=26 Participants • Maternal race provided
|
4 Participants
n=50 Participants • Maternal race provided
|
|
Gestational age (weeks)
|
38.7 weeks
STANDARD_DEVIATION 1.9 • n=23 Participants • missing data in 1 Epo subject
|
38.7 weeks
STANDARD_DEVIATION 1.6 • n=26 Participants • missing data in 1 Epo subject
|
38.7 weeks
STANDARD_DEVIATION 1.7 • n=49 Participants • missing data in 1 Epo subject
|
|
Maternal education
High school or less
|
10 Participants
n=21 Participants • missing data in 3 Epo and 2 placebo subjects
|
10 Participants
n=24 Participants • missing data in 3 Epo and 2 placebo subjects
|
20 Participants
n=45 Participants • missing data in 3 Epo and 2 placebo subjects
|
|
Maternal education
Some college or university
|
5 Participants
n=21 Participants • missing data in 3 Epo and 2 placebo subjects
|
7 Participants
n=24 Participants • missing data in 3 Epo and 2 placebo subjects
|
12 Participants
n=45 Participants • missing data in 3 Epo and 2 placebo subjects
|
|
Maternal education
College graduate, or post-grad
|
6 Participants
n=21 Participants • missing data in 3 Epo and 2 placebo subjects
|
7 Participants
n=24 Participants • missing data in 3 Epo and 2 placebo subjects
|
13 Participants
n=45 Participants • missing data in 3 Epo and 2 placebo subjects
|
|
Birth weight (g)
|
3556 grams
STANDARD_DEVIATION 618 • n=24 Participants
|
3243 grams
STANDARD_DEVIATION 512 • n=26 Participants
|
3393 grams
STANDARD_DEVIATION 581 • n=50 Participants
|
|
Large for gestational age
|
6 Participants
n=24 Participants
|
1 Participants
n=26 Participants
|
7 Participants
n=50 Participants
|
|
Severe Sarnat encephalopathy
|
5 Participants
n=24 Participants
|
4 Participants
n=26 Participants
|
9 Participants
n=50 Participants
|
|
5 minute Apgar
0-3 (critically low)
|
11 Participants
n=23 Participants • missing data in 1 Epo and 1 placebo subject
|
14 Participants
n=25 Participants • missing data in 1 Epo and 1 placebo subject
|
25 Participants
n=48 Participants • missing data in 1 Epo and 1 placebo subject
|
|
5 minute Apgar
4-6 (below normal)
|
10 Participants
n=23 Participants • missing data in 1 Epo and 1 placebo subject
|
10 Participants
n=25 Participants • missing data in 1 Epo and 1 placebo subject
|
20 Participants
n=48 Participants • missing data in 1 Epo and 1 placebo subject
|
|
5 minute Apgar
7-10 (normal)
|
2 Participants
n=23 Participants • missing data in 1 Epo and 1 placebo subject
|
1 Participants
n=25 Participants • missing data in 1 Epo and 1 placebo subject
|
3 Participants
n=48 Participants • missing data in 1 Epo and 1 placebo subject
|
|
10 minute Apgar
0-3
|
5 Participants
n=21 Participants • missing data in 3 Epo and 1 placebo subject
|
7 Participants
n=25 Participants • missing data in 3 Epo and 1 placebo subject
|
12 Participants
n=46 Participants • missing data in 3 Epo and 1 placebo subject
|
|
10 minute Apgar
4-6
|
13 Participants
n=21 Participants • missing data in 3 Epo and 1 placebo subject
|
11 Participants
n=25 Participants • missing data in 3 Epo and 1 placebo subject
|
24 Participants
n=46 Participants • missing data in 3 Epo and 1 placebo subject
|
|
10 minute Apgar
7-10
|
3 Participants
n=21 Participants • missing data in 3 Epo and 1 placebo subject
|
7 Participants
n=25 Participants • missing data in 3 Epo and 1 placebo subject
|
10 Participants
n=46 Participants • missing data in 3 Epo and 1 placebo subject
|
|
Resuscitation > 10 minutes
|
21 Participants
n=24 Participants
|
21 Participants
n=26 Participants
|
42 Participants
n=50 Participants
|
|
Chest compressions
|
8 Participants
n=24 Participants
|
11 Participants
n=26 Participants
|
19 Participants
n=50 Participants
|
|
Lowest pH
|
6.9 pH
STANDARD_DEVIATION 0.2 • n=20 Participants • missing data from 4 Epo and 2 placebo subjects
|
7.0 pH
STANDARD_DEVIATION 0.2 • n=24 Participants • missing data from 4 Epo and 2 placebo subjects
|
6.9 pH
STANDARD_DEVIATION 0.2 • n=44 Participants • missing data from 4 Epo and 2 placebo subjects
|
|
aEEG severe abnormal background
|
7 Participants
n=22 Participants • missing data from 2 Epo and 2 placebo subjects
|
7 Participants
n=24 Participants • missing data from 2 Epo and 2 placebo subjects
|
14 Participants
n=46 Participants • missing data from 2 Epo and 2 placebo subjects
|
|
Maternal chorioamnionitis
|
4 Participants
n=24 Participants
|
3 Participants
n=26 Participants
|
7 Participants
n=50 Participants
|
|
Delivery mode
Spontaneous vaginal
|
5 Participants
n=24 Participants
|
9 Participants
n=26 Participants
|
14 Participants
n=50 Participants
|
|
Delivery mode
Vacuum or forceps
|
1 Participants
n=24 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=50 Participants
|
|
Delivery mode
Elective cesarean
|
1 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=50 Participants
|
|
Delivery mode
Emergency cesarean
|
17 Participants
n=24 Participants
|
15 Participants
n=26 Participants
|
32 Participants
n=50 Participants
|
|
Sentinel event
|
7 Participants
n=24 Participants
|
7 Participants
n=26 Participants
|
14 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeksThe investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit
Outcome measures
| Measure |
Erythropoietin
n=24 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=26 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Markers of Organ Function
Persistent pulmonary hypertension
|
5 participants
|
4 participants
|
|
Markers of Organ Function
Disseminated intravascular coagulation
|
3 participants
|
5 participants
|
|
Markers of Organ Function
Sepsis (positive blood culture and antibiotics >=7
|
0 participants
|
5 participants
|
|
Markers of Organ Function
Renal dysfunction (creatinine > 1.5)
|
4 participants
|
5 participants
|
|
Markers of Organ Function
Hypertension (requiring anti-hypertensive)
|
1 participants
|
0 participants
|
|
Markers of Organ Function
Polycythemia (requiring intervention)
|
0 participants
|
0 participants
|
|
Markers of Organ Function
Death during birth hospitalization
|
2 participants
|
5 participants
|
|
Markers of Organ Function
Cardiopulmonary collapse within 2 hours of drug
|
1 participants
|
0 participants
|
|
Markers of Organ Function
Thrombosis of major vessel
|
1 participants
|
1 participants
|
|
Markers of Organ Function
Unexpected event related to study drug
|
0 participants
|
0 participants
|
|
Markers of Organ Function
Liver dysfunction (ALT >100 IU/L)
|
10 participants
|
6 participants
|
|
Markers of Organ Function
Hypotension (requiring inotrope or vasopressor)
|
9 participants
|
12 participants
|
|
Markers of Organ Function
Thrombocytopenia (platelet < 100,000 per uL)
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 12 monthsThe AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items), \& standing (16 items). Each item is scored as 'observed' or 'not observed'. Total score range is 0-58, scored as percentile ranks after a raw score is obtained and plotted against age at testing, based on validated norms.
Outcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Alberta Infant Motor Scale (AIMS)
|
53.5 percentile
Standard Deviation 5.2
|
42.8 percentile
Standard Deviation 19.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsA 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care sub-scale score range 17-68. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Total scale range is 50-200. Higher scores mean higher functioning. Lower scores mean lower functioning.
Outcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Warner Initial Developmental Evaluation (WIDEA)
Total score (50-200)
|
122 units on a scale
Standard Deviation 14
|
110 units on a scale
Standard Deviation 31
|
|
Warner Initial Developmental Evaluation (WIDEA)
Self-care (17-68)
|
36.7 units on a scale
Standard Deviation 5.1
|
33.8 units on a scale
Standard Deviation 7.7
|
|
Warner Initial Developmental Evaluation (WIDEA)
Mobility (9-36)
|
28.6 units on a scale
Standard Deviation 3.8
|
23.8 units on a scale
Standard Deviation 8.9
|
|
Warner Initial Developmental Evaluation (WIDEA)
Communication (13-52)
|
28.2 units on a scale
Standard Deviation 5.1
|
25.5 units on a scale
Standard Deviation 8.8
|
|
Warner Initial Developmental Evaluation (WIDEA)
Social Cognition (11-44)
|
28.8 units on a scale
Standard Deviation 6.4
|
26.9 units on a scale
Standard Deviation 8.9
|
POST_HOC outcome
Timeframe: 6 monthsA 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care score range 7-28. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Higher the score means higher functioning. Lower scores means lower functioning.
Outcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=21 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
Mobility (9-36)
|
14.1 units on a scale
Standard Deviation 2.7
|
12.4 units on a scale
Standard Deviation 2.7
|
|
Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
Communication (13-52)
|
16.4 units on a scale
Standard Deviation 3.2
|
15.3 units on a scale
Standard Deviation 2.8
|
|
Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
Total score (50-200)
|
75.3 units on a scale
Standard Deviation 9.1
|
68.8 units on a scale
Standard Deviation 10.7
|
|
Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
Self-care (7-28)
|
28.1 units on a scale
Standard Deviation 4.2
|
26.1 units on a scale
Standard Deviation 4.7
|
|
Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
Social Cognition (11-44)
|
16.7 units on a scale
Standard Deviation 4.5
|
14.9 units on a scale
Standard Deviation 3.2
|
POST_HOC outcome
Timeframe: 12-monthsModerate to severe neurodevelopmental impairment at 12 months was defined as AIMS less than 5th percentile for age, or WIDEA more than 2 standard deviations below the mean based on normative data from typically developing infants at 12.9 months of age.
Outcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Moderate to Severe Neurodevelopmental Impairment
|
2 Participants
|
5 Participants
|
POST_HOC outcome
Timeframe: 12-monthsOutcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Growth Parameters: Weight
|
9.9 kg
Standard Deviation 1.4
|
9.7 kg
Standard Deviation 1.2
|
POST_HOC outcome
Timeframe: 12-monthsOutcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Growth Parameters: Height
|
74.3 cm
Standard Deviation 3.2
|
71.7 cm
Standard Deviation 6.2
|
POST_HOC outcome
Timeframe: 12-monthsOutcome measures
| Measure |
Erythropoietin
n=21 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=20 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Growth Parameters: Head Circumference
|
45.7 cm
Standard Deviation 1.6
|
45.5 cm
Standard Deviation 2.1
|
POST_HOC outcome
Timeframe: neonatal hospitalizationPopulation: For subjects randomized to Erythropoietin, age at MRI was 5.6 days (SD 2.8) and subjects received 3.7 (SD 0.8) doses before MRI. For subjects randomized to placebo (normal saline), age at MRI was 4.9 days (SD 1.4) and subjects received 3.4 (SD 0.8) doses before MRI.
Outcome measures
| Measure |
Erythropoietin
n=23 Participants
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline
n=25 Participants
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: Brainstem
|
1 participants
|
4 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: Cerebellar
|
0 participants
|
5 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: >=2 regions injured
|
7 participants
|
14 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Global brain injury score: None (0)
|
8 participants
|
3 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Global brain injury score: Mild (1-11)
|
14 participants
|
11 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Global brain injury score: Moderate (12-31)
|
0 participants
|
6 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Global brain injury score: Severe (>=32)
|
1 participants
|
5 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: Subcortical
|
7 participants
|
17 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: Cortical
|
4 participants
|
9 participants
|
|
Brain Injury, as Determined by Neonatal Brain MRI
Presence of brain injury: White matter
|
12 participants
|
15 participants
|
Adverse Events
Erythropoietin - Infants
Serious events: 3 serious events
Other events: 17 other events
Deaths: 2 deaths
Normal Saline - Infants
Serious events: 6 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Erythropoietin - Infants
n=24 participants at risk
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline - Infants
n=26 participants at risk
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
General disorders
Cardiopulmonary collapse within 2h of drug
|
4.2%
1/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
0.00%
0/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Blood and lymphatic system disorders
Thrombosis of major vessel
|
4.2%
1/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
3.8%
1/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
General disorders
Unexpected event related to study drug
|
0.00%
0/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
0.00%
0/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
General disorders
Death during birth hospitalization
|
8.3%
2/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
19.2%
5/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
Other adverse events
| Measure |
Erythropoietin - Infants
n=24 participants at risk
Erythropoietin: 1000 U/kg/dose IV x 5 doses
|
Normal Saline - Infants
n=26 participants at risk
Normal saline: placebo: NS IV x 5 doses
|
|---|---|---|
|
Hepatobiliary disorders
Liver dysfunction (ALT >100 IU/L)
|
41.7%
10/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
23.1%
6/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Vascular disorders
Hypotension (requiring inotrope or vasopressor)
|
37.5%
9/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
46.2%
12/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Blood and lymphatic system disorders
Thrombocytopenia (platelet < 100,000 per uL)
|
25.0%
6/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
38.5%
10/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Persistent pulmonary hypertension
|
20.8%
5/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
15.4%
4/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
12.5%
3/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
19.2%
5/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Infections and infestations
Sepsis (positive blood culture and antibiotics >=7)
|
0.00%
0/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
19.2%
5/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Renal and urinary disorders
Renal dysfunction (creatinine >1.5)
|
16.7%
4/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
19.2%
5/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Vascular disorders
Hypertension (requiring anti-hypertensive)
|
4.2%
1/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
0.00%
0/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
|
Blood and lymphatic system disorders
Polycythemia (requiring intervention)
|
0.00%
0/24
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
0.00%
0/26
Adverse Events were only monitored for infants. No Adverse Event data were collected for mothers.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place