Trial Outcomes & Findings for Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation (NCT NCT01220687)
NCT ID: NCT01220687
Last Updated: 2020-08-19
Results Overview
To investigate whether iNO decreases the supplemental oxygen exposure in the preterm infants who require continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) during resuscitation as per Neonatal Resuscitation Program (NRP) protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
20 minutes
Results posted on
2020-08-19
Participant Flow
Women admitted in preterm labor with gestational ages of 25 0/7 to 31 6/7 weeks gestation were approached for prenatal consent. 171 mothers were identified, 95 mothers consented
64 consented mothers or infants met subsequent exclusion criteria. Of those, only 33 were enrolled at time of delivery. Most common exclusion was aging out of gestational age limit, precipitous delivery, or no team available.
Participant milestones
| Measure |
Placebo 20ppm
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Baseline characteristics by cohort
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.1 Weeks
n=5 Participants
|
28.6 Weeks
n=7 Participants
|
28.4 Weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Birthweight
|
1105 Grams
n=5 Participants
|
1145 Grams
n=7 Participants
|
1105 Grams
n=5 Participants
|
|
Apgar Score at one minute
|
5 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
|
Apgar Score at 5 minutes
|
8 units on a scale
n=5 Participants
|
7 units on a scale
n=7 Participants
|
7.5 units on a scale
n=5 Participants
|
|
Any Antenatal Steroid
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Chorioamnionitis
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Rupture of Membranes (ROM) greater than 18 hours
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Maternal Preeclampsia
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutesTo investigate whether iNO decreases the supplemental oxygen exposure in the preterm infants who require continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) during resuscitation as per Neonatal Resuscitation Program (NRP) protocol.
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Maximum Factional Inspired Oxygen Percent (FiO2)
|
48 percentage of Inspired Oxygen
Interval 34.73 to 68.2
|
39 percentage of Inspired Oxygen
Interval 20.98 to 53.26
|
PRIMARY outcome
Timeframe: 20 minutesFiO2 \>60% at any 5 second increment during the study period of 20 minutes for each infant in each arm.
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Rate of Hyperoxia
|
708 Observations on >60% FiO2
|
370 Observations on >60% FiO2
|
PRIMARY outcome
Timeframe: at 20 minutes (end of study)Oxygen saturations as described as preductal (right hand) as well as post ductal (either foot) and measured as percent of saturated hemoglobin by pulse oximetry.
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Pre and Postductal Saturation Levels
Preductal Saturation
|
90.5 Percent Saturation
Standard Deviation 5.7
|
82.8 Percent Saturation
Standard Deviation 13.8
|
|
Pre and Postductal Saturation Levels
Postductal Saturation
|
79.9 Percent Saturation
Standard Deviation 25.8
|
78.2 Percent Saturation
Standard Deviation 20
|
PRIMARY outcome
Timeframe: 5, 10 and 20 minutes on studyMeasured and recorded heart rates every 5 seconds on study as described as beats per minute (BPM)
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Heart Rate During Resuscitation
BPM at 5 minutes
|
139 BPM
Standard Deviation 53
|
130 BPM
Standard Deviation 46
|
|
Heart Rate During Resuscitation
BPM at 10 minutes
|
161 BPM
Standard Deviation 53
|
149 BPM
Standard Deviation 46
|
|
Heart Rate During Resuscitation
BPM at 20 minutes
|
168 BPM
Standard Deviation 53
|
158 BPM
Standard Deviation 46
|
PRIMARY outcome
Timeframe: by end of study, 20 minutesInfants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management.
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Need for Intubation
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Hospital DischargeIntraventricular Hemorrhage (IVH) \> Gr 2 as described by radiographic scale as described in "Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm.", Papile L A; Burstein J; Burstein R; Koffler H, The Journal of pediatrics, (1978 Apr) Vol. 92, No. 4, pp. 529-34. Journal code: 0375410. ISSN: 0022-3476. L-ISSN: 0022-3476. IVH classification systems Papile system Grade I Subependymal hemorrhage Grade II IVH without ventricular dilation Grade III IVH with ventricular dilation Grade IV Extensive IVH with parenchymal involvement
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Intraventricular Hemorrhage > Grade 2
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to infant discharge from the hospitalCount of patients requiring either pharmacologic or surgical treatment for persistent PDA
Outcome measures
| Measure |
Placebo 20ppm
n=14 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=14 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to infant discharge from the hospitalPopulation: 2 of the 14 patients in the placebo arm died and had no ROP exam, 3 of the 14 patients in the INO Group died and had no ROP exam.
Staging of any retinal disease as described by the standard screening by the American Association for Pediatric Ophthalmology and Strabismus. Only infants who survived to obtain retinal imaging are included (12 in Placebo arm and 11 in INO arm)
Outcome measures
| Measure |
Placebo 20ppm
n=12 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=11 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Retinopathy of Prematurity (ROP)> Stage 2
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to infant discharge from the hospitalPopulation: 2 of the 14 patients in the placebo arm died were not included in the analysis, 1 of the 14 patients in the INO Group was excluded for pulmonary hypoplasia..
endotracheal or other airway placement and mechanical ventilation in days, days of non-invasive ventilation as described as nasal ventilation, CPAP, high flow and low flow oxygen as counted in days. Only infants who survived to discharge were included in this analysis.
Outcome measures
| Measure |
Placebo 20ppm
n=12 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=13 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)
Mechanical Ventilation
|
14 Days
Interval 2.0 to 29.0
|
8.5 Days
Interval 1.5 to 26.0
|
|
Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)
NIV
|
15 Days
Interval 3.0 to 23.0
|
20.5 Days
Interval 6.5 to 31.0
|
|
Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)
LOS
|
52 Days
Interval 48.0 to 88.0
|
70.5 Days
Interval 49.0 to 108.5
|
SECONDARY outcome
Timeframe: at 36 weeks adjusted gestational age of participantBronchopulmonary Dysplasia as described as oxygen need at 36 weeks adjusted gestational age. Only infants who survived to 36 weeks gestation were included in this analysis.
Outcome measures
| Measure |
Placebo 20ppm
n=12 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=13 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Bronchopulmonary Dysplasia
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at any time during study periodLate Onset Sepsis as described as infection after day 5 of life. This would include all patients who survived to day of life 5.
Outcome measures
| Measure |
Placebo 20ppm
n=13 Participants
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Nitrogen: Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
iNO 20 Ppm
n=12 Participants
Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
iNO: Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
|---|---|---|
|
Late Onset Sepsis
|
2 Participants
|
0 Participants
|
Adverse Events
Placebo 20ppm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
iNO 20 Ppm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Krishnamurhty Sekar, MD, Professor of Pediatrics
OUHSC College of Medicine, Pediatrics, Neonatal-Perinatal Medicine
Phone: 405-271-5215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place