We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01534481
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : February 6, 2023
Last Update Posted : February 6, 2023
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Infant, Newborn
Infant, Small for Gestational Age
Infant, Extremely Low Birth Weight
Interventions Biological: Donor Milk
Dietary Supplement: Preterm Formula
Enrollment 483
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description Pasteurized donor milk Preterm infant formula
Period Title: Overall Study
Started 239 244
Complete Data for BSID III Cognitive Score at 22-26 Months 175 192
Died After Discharge 5 7
Died Before Discharge 24 18
Survived to Discharge 215 226
Completed [1] 204 217
Not Completed 35 27
Reason Not Completed
Lost to Follow-up             29             24
Incomplete Follow-up or No Study Data             6             3
[1]
Death or BSID III cognitive score at 22-26 months
Arm/Group Title DONORMILK FORMULA Total
Hide Arm/Group Description Pasteurized donor milk Preterm infant formula Total of all reporting groups
Overall Number of Baseline Participants 239 244 483
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 239 participants 244 participants 483 participants
26  (1.8) 26.1  (1.6) 26  (1.7)
[1]
Measure Description: Age refers to the infant and is measured as gestational age in weeks
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 244 participants 483 participants
Female
133
  55.6%
116
  47.5%
249
  51.6%
Male
106
  44.4%
128
  52.5%
234
  48.4%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 244 participants 483 participants
Black
126
  52.7%
121
  49.6%
247
  51.1%
Missing
4
   1.7%
1
   0.4%
5
   1.0%
Other
11
   4.6%
14
   5.7%
25
   5.2%
White
98
  41.0%
108
  44.3%
206
  42.7%
[1]
Measure Description: Race
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 244 participants 483 participants
Hispanic or Latino
37
  15.5%
31
  12.7%
68
  14.1%
Missing
1
   0.4%
1
   0.4%
2
   0.4%
Not Hispanic or Latino
201
  84.1%
212
  86.9%
413
  85.5%
[1]
Measure Description: Ethnicity
Weight of Infant at Birth   [1] 
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 239 participants 244 participants 483 participants
848.6  (232) 842.5  (219.8) 845.5  (225.8)
[1]
Measure Description: Weight of the infant at birth, in grams
Maternal Education   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 244 participants 483 participants
College degree/more
17
   7.1%
23
   9.4%
40
   8.3%
High school degree
82
  34.3%
93
  38.1%
175
  36.2%
Less than high school degree
64
  26.8%
57
  23.4%
121
  25.1%
Missing
19
   7.9%
17
   7.0%
36
   7.5%
Partial college
57
  23.8%
54
  22.1%
111
  23.0%
[1]
Measure Description: Maternal education categories
1.Primary Outcome
Title Bayley Scales of Infant Development (BSID) Cognitive Composite Score
Hide Description Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who died or were followed at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 206 217
Mean (Standard Deviation)
Unit of Measure: Score on a scale
80.7  (17.4) 81.1  (16.7)
2.Secondary Outcome
Title Total Deaths Before Discharge
Hide Description Infant died before discharge home.
Time Frame From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 239 244
Measure Type: Count of Participants
Unit of Measure: Participants
Death before discharge
24
  10.0%
18
   7.4%
Survival to discharge
215
  90.0%
226
  92.6%
3.Secondary Outcome
Title Late Onset Sepsis (LOS)
Hide Description Number of infants diagnosed with LOS
Time Frame From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 239 244
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data
1
   0.4%
0
   0.0%
Late-onset sepsis
47
  19.7%
37
  15.2%
No late-onset sepsis
191
  79.9%
207
  84.8%
4.Secondary Outcome
Title Necrotizing Enterocolitis (NEC)
Hide Description Number of infants diagnosed with NEC
Time Frame From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 239 244
Measure Type: Count of Participants
Unit of Measure: Participants
Necrotizing enterocolitis
10
   4.2%
22
   9.0%
No necrotizing enterocolitis
229
  95.8%
222
  91.0%
5.Secondary Outcome
Title Death or Necrotizing Enterocolitis (NEC)
Hide Description A composite outcome that measures the occurrence of death or NEC
Time Frame From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 239 244
Measure Type: Count of Participants
Unit of Measure: Participants
Death or NEC
27
  11.3%
33
  13.5%
Survival without NEC
212
  88.7%
211
  86.5%
6.Secondary Outcome
Title Change in Weight-for-age Z-score During Study
Hide Description

Weight-for-age Z-scores were calculated at both baseline (study initiation) and study end (within one week of last study data collected) based on Fenton growth curves (2013). This outcome represents the change in weight-for-age Z-score during the course of the study (i.e., the Z-score at baseline was subtracted from the Z-score at study end).

A value of 0 represents that the infant's weight-for-age Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's weight-for-age Z-score during the study; negative values indicate the decrease in the infant's weight-for-age Z-score during the study.
Time Frame During Study Intervention, the time between study randomization and discontinuation of study protocol. Infants exited from the study protocol 1-2 weeks prior to anticipated hospital discharge or 120 days, whichever is sooner
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants with non-missing data for weight at both the beginning and the end of the study.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 235 243
Mean (Standard Deviation)
Unit of Measure: Change in Z-score (difference)
-0.4  (0.9) -0.1  (0.9)
7.Secondary Outcome
Title Bayley Scales of Infant Development (BSID) Motor Composite Score
Hide Description Mean motor composite score (standardized mean 100, range 44-155). Subjects who died prior to follow-up assigned the score of 44. (lower scores indicating greater impairment)
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who died or were followed at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 202 213
Mean (Standard Deviation)
Unit of Measure: Score on a scale
80.3  (21.6) 80.1  (19.9)
8.Secondary Outcome
Title Bayley Scales of Infant Development (BSID) Language Composite Score
Hide Description Mean language composite score (standardized mean 100, range 46-155). Subjects who died prior to follow-up assigned the score of 46. (lower scores indicating greater impairment)
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who died or were followed at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 203 212
Mean (Standard Deviation)
Unit of Measure: Score on a scale
76.7  (19.6) 75.8  (18.6)
9.Secondary Outcome
Title Moderate to Severe Cerebral Palsy
Hide Description Number of infants with moderate or severe grade of cerebral palsy
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 188 199
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data
3
   1.6%
2
   1.0%
Moderate-severe cerebral palsy
14
   7.4%
20
  10.1%
No moderate-severe cerebral palsy
171
  91.0%
177
  88.9%
10.Secondary Outcome
Title Neurodevelopmental Impairment (NDI).
Hide Description Number of infants with NDI. NDI is defined as any of the following: Gross Motor Function Classification System score greater than or equal to 2, Bayley III cognitive or motor score less than 85 (1 standard deviation), Vision Impairment or Hearing impairment
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 188 199
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data
11
   5.9%
10
   5.0%
Neurodevelopmental impairment
89
  47.3%
98
  49.2%
No neurodevelopmental impairment
88
  46.8%
91
  45.7%
11.Secondary Outcome
Title Profound Impairment
Hide Description Number of infants with profound impairment.
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 188 199
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data
4
   2.1%
5
   2.5%
No profound NDI
154
  81.9%
152
  76.4%
Profound NDI
30
  16.0%
42
  21.1%
12.Secondary Outcome
Title Death or Neurodevelopmental Impairment (NDI)
Hide Description A composite outcome that measures the occurrence of death through 22-26 months or NDI.
Time Frame At 22-26 months corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants who died or were followed (or adjudicated) at 22-26 months.
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description:
Pasteurized donor milk
Preterm infant formula
Overall Number of Participants Analyzed 217 224
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data
11
   5.1%
10
   4.5%
Death or NDI
118
  54.4%
123
  54.9%
Survival without NDI
88
  40.6%
91
  40.6%
Time Frame From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donor Milk Formula
Hide Arm/Group Description Pasteurized donor milk Preterm infant formula
All-Cause Mortality
Donor Milk Formula
Affected / at Risk (%) Affected / at Risk (%)
Total   29/239 (12.13%)      25/244 (10.25%)    
Hide Serious Adverse Events
Donor Milk Formula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/239 (20.08%)      47/244 (19.26%)    
Cardiac disorders     
Bradycardia neonatal † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Cardiac arrest neonatal † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Cardiac failure congestive † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Congenital, familial and genetic disorders     
Heart disease congenital † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Patent ductus arteriosus † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Renal hypoplasia † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Gastrointestinal disorders     
Ascites † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Colitis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Diarrhea neonatal † 1  1/239 (0.42%)  2 0/244 (0.00%)  0
Ileal stenosis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Necrotising enterocolitis neonatal † 1  13/239 (5.44%)  13 20/244 (8.20%)  21
Neonatal intestinal obstruction † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal intestinal perforation † 1  4/239 (1.67%)  4 1/244 (0.41%)  5
Pneumoperitoneum † 1  2/239 (0.84%)  2 0/244 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinaemia neonatal † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal cholestasis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Infections and infestations     
Adenovirus infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
CNS ventriculitis † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Cytomegalovirus infection † 1  2/239 (0.84%)  2 2/244 (0.82%)  2
Disseminated aspergillosis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Gastroenteritis rotavirus † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Neonatal infection † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal pneumonia † 1  0/239 (0.00%)  0 2/244 (0.82%)  2
Nosocomial infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Rhinovirus infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Sepsis neonatal † 1  14/239 (5.86%)  18 14/244 (5.74%)  14
Urinary tract infection fungal † 1  0/239 (0.00%)  0 2/244 (0.82%)  2
Metabolism and nutrition disorders     
Feeding intolerance † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Metabolic acidosis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal hypoglycemia † 1  2/239 (0.84%)  2 0/244 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteopenia † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Nervous system disorders     
Cerebral ventricle dilatation † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Haemorrhage intracranial † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Hypoxic-ischaemic encephalopathy † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Intraventricular haemorrhage neonatal † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal seizure † 1  0/239 (0.00%)  0 2/244 (0.82%)  2
Renal and urinary disorders     
Acute kidney injury † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Chronic kidney disease † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Renal failure neonatal † 1  1/239 (0.42%)  1 1/244 (0.41%)  1
Renal tubular acidosis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary dysplasia † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal respiratory distress † 1  1/239 (0.42%)  1 4/244 (1.64%)  4
Neonatal respiratory distress syndrome † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal respiratory failure † 1  1/239 (0.42%)  1 3/244 (1.23%)  3
Pleural effusion † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Pulmonary air leakage † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Pulmonary haemorrhage neonatal † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Pulmonary hypertension † 1  1/239 (0.42%)  1 2/244 (0.82%)  2
Vascular disorders     
Labile blood pressure † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Neonatal hypotension † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Donor Milk Formula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/239 (7.95%)      17/244 (6.97%)    
Congenital, familial and genetic disorders     
Patent ductus arteriosus † 1  2/239 (0.84%)  2 0/244 (0.00%)  0
Eye disorders     
Retinopathy of prematurity † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Gastroesophageal reflux disease † 1  1/239 (0.42%)  2 0/244 (0.00%)  0
Necrotising enterocolitis neonatal † 1  2/239 (0.84%)  2 9/244 (3.69%)  9
Hepatobiliary disorders     
Acute on chronic liver failure † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Neonatal cholestasis † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Infections and infestations     
Coronavirus infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Cytomegalovirus infection † 1  1/239 (0.42%)  1 3/244 (1.23%)  3
Gastroenteritis rotavirus † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Metapneumovirus infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Neonatal infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Sepsis neonatal † 1  13/239 (5.44%)  15 6/244 (2.46%)  6
Staphylococcal infection † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Metabolism and nutrition disorders     
Feeding intolerance † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Hyperglycaemia † 1  0/239 (0.00%)  0 1/244 (0.41%)  2
Metabolic acidosis † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal hypoglycemia † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Nervous system disorders     
Intraventricular haemorrhage neonatal † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Neonatal seizure † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Pregnancy, puerperium and perinatal conditions     
Hypothermia neonatal † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Renal and urinary disorders     
Neonatal anuria † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Respiratory, thoracic and mediastinal disorders     
Apnea † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Apnea Neonatal † 1  1/239 (0.42%)  1 0/244 (0.00%)  0
Neonatal respiratory distress † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
Vascular disorders     
Hypertension neonatal † 1  0/239 (0.00%)  0 1/244 (0.41%)  1
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators must adhere to the Neonatal Research Network Publication Policies
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tarah Colaizy
Organization: University of Iowa
Phone: 319-356-3508
EMail: tarah-colaizy@uiowa.edu
Layout table for additonal information
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01534481    
Other Study ID Numbers: NICHD-NRN-0047
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
First Submitted: February 13, 2012
First Posted: February 16, 2012
Results First Submitted: November 29, 2022
Results First Posted: February 6, 2023
Last Update Posted: February 6, 2023