Phase 2 N=149 Aerosolized Surfactant in Neonatal RDS
Respiratory Distress Syndrome, Newborn
Primary: Number of Participants With Adverse Events as a Measure of Safety and Feasibility — 3; 8; 4; 12 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=52 Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Respiratory Depression · Obstructive Sleep Apnea
Primary: Respiratory Depression Following Opioids — -38.1; -37.1 percentage of change from baseline
N/A N=31 Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Respiratory Distress Syndrome in Premature Infants · Very Low Birth Weight Baby
Primary: Maximum Factional Inspired Oxygen Percent (FiO2) — 48; 39 percentage of Inspired Oxygen — p=0.0012
Phase 4 N=21 Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Caffeine
Primary: Intubation — 3; 7 participants
Phase 2 N=10 Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal Abstinence Syndrome · Neonatal Opiate Withdrawal Syndrome
Primary: Buprenorphine Pharmacokinetics
N/A N=410 Monitoring Neonatal Resuscitation Trial
Resuscitation · Neonatal Prematurity · Positive-Pressure Respiration
Primary: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg — 30.2; 30.7 percentage of inflations — p=0.896
N/A N=1,493 A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies
Primary: Duration of Invasive Mechanical Ventilation — 6.3; 7.8; 7.3 day
N/A N=211 Detecting Post-Operative Respiratory Depression in Children
Respiratory Depression
Primary: Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions — 56; 58; 8; 15 participants
N/A N=34 Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Bronchopulmonary Dysplasia
Primary: Number of Days Being Intubated — 12.4; 6.2 days
N/A N=40 Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Heart Disease Congenital Complex
Primary: Incidence of Low Cardiac Output Syndrome (LCOS) — 57; 26 percentage of patients — p=0.049
N/A N=36 Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Abdominal Surgery · Thoracic Surgery
Primary: Morphine Consumption — 0.014; 0.036 mg/kg/hr
N/A N=340 NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Preterm Infants
Primary: Number of Participants Who Required Intubation — 26; 15 Participants
Phase 2 N=123 A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Respiratory Distress Syndrome, Newborn
Primary: Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio — 3.33; 3.31; 3.36; 3.55 SpO2/FiO2 ratio — p=0.930
N/A N=200 Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
Prematurity · Respiratory Distress Syndrome
Primary: Need for Endotracheal Ventilation in the First 72 hs of Life — 34; 25 participants — p=<0.05
N/A N=63 Neonatal Resuscitation - Sustained Inflations
Premature Birth
Primary: Expiratory Tidal Volume — 153; 194 ml/kg/min
Phase 3 N=63 Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Primary: Length of Treatment — 15; 28 days — p=<0.05
Phase 3 N=173 Premedication Trial for Tracheal Intubation of the NEOnate
Premedication · Endotracheal Intubation
Primary: Number of Patients With Prolonged Desaturation — 54; 53 Participants — p=0.38
Phase 2 N=22 Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
Epilepsy · SUDEP
Primary: Study Recruitment Rate — 3.8 participants/3 months
Phase 2 N=80 Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Respiratory Distress Syndrome
Primary: Peri-Dosing Events — 0; 0; 0; 1 participants
Phase 2 N=42 Maternal Buprenorphine-naloxone Treatment and the Infant
Maternal Opioid Use Disorder · Opioid Exposed Infant
Primary: Fetal Heart Rate at 24 Weeks — 143.64 beats per minute
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=19 Non-invasive Intervention for Apnea of Prematurity
Apnea of Prematurity · Hypoxia · Bradycardia
Primary: Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention — 284.13; 174.27 breathing pauses
Phase 3 N=117 Improving Outcomes in Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal
Primary: Length of Hospital Stay (LOS) — 21.8; 23.2 days
Phase 2 N=196 Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
Narcotic Addiction · Neonatal Abstinence Syndrome
Primary: Number of Participants With Neonatal Abstinence Syndrome — 22; 26 Participants — p=0.2
Phase 4 N=28 Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Primary: Length of Hospital Stay — 17.9; 16.1 days
N/A N=80 Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Neonatal Respiratory Distress Syndrome · Extremely Low Birth Weight Infant (ELBW) · BronchoPulmonary Dysplasia
Primary: Number of Participants With Successful Wean Off CPAP at the First Attempt — 31; 30 Participants
N/A N=8 tAN to Mitigate Withdrawal Behaviors in Neonates
Neonatal Abstinence Syndrome
Primary: Number of Subjects With no Adverse Events Related to Bradycardia (HR < 80 Bpm), Worsening of Swallowing or Feeding, Skin Irritation, or Elevation of Neonatal Infant Pain…
Phase 2 N=124 Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Bronchopulmonary Dysplasia
Primary: Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality — 1; 2; 24; 25 Participants
Phase 3 N=648 Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Primary: Death or Chronic Lung Disease — 76; 68; 62 participants
Phase 3 N=85 Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) · Bronchopulmonary Dysplasia
Primary: SP-B Content — 19.9; 13.3 Total surfactant protein (% of PL)