Clinical trials: Preterm Babies
Bronchopulmonary Dysplasia
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated…
- Trial name
- TOLSURF (NCT01022580)
- Testing
- Infasurf surfactant (ONY, Inc.)
- Where
- 21 sites in United States
- Volunteers
- 511 people
- Sponsor
- Roberta Ballard
Preterm Birth, Pain
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.
- Trial name
- NCT04286269
- Testing
- Music Based Intervention
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Prematurity
A Clinical Trial of A Pacifier-Activated Music Player
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing.
- Trial name
- NCT01600586
- Testing
- Pacifier-Activated-Lullaby system (PAL).
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
PPROM, Respiratory Distress Syndrome in Premature Infants
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care…
- Trial name
- NCT02939742
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Respiratory Distress Syndrome, Newborn
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube…
- Trial name
- NCT01042600
- Testing
- Endotracheal tube insertion, Laryngeal mask airway insertion
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Albany Medical College
Neonatal, Premature Birth
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as…
- Conditions
- Neonatal, Premature Birth, Respiratory Distress Syndrome
- Trial name
- NCT04295564
- Testing
- Additional 2 weeks of CPAP
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cynthia McEvoy
Enteral Feeding
Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Oral feeding is one of the primary functions of the neonatal brain. In preterm infant population, competency at oral feeding is one of the major milestones in preparation for discharge.
- Trial name
- NCT05181020
- Testing
- Maternal Voice Exposure
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Connecticut Children's Medical Center
Bronchopulmonary Dysplasia
Inhaled Tobramycin in BPD
This study is an open-label, phase 1, sequential dose escalation trial seeking to establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very…
- Trial name
- NCT04560179
- Testing
- Tobramycin solution for inhalation 78mg dose, Tobramycin solution for inhalation 150mg dose, Tobramycin solution for inhalation 216mg dose
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Erik Allen Jensen
Severe Bronchopulmonary Dysplasia
Aerosolized Albuterol Use in Severe BPD
Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU).
- Trial name
- NCT02766673
- Testing
- Albuterol Sulfate, Sterile Saline
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital of Philadelphia
Infant, Premature, Premature Birth
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm…
- Trial name
- NCT00579553
- Testing
- Intramuscular Progesterone, Vaginal Progesterone
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Prematurity
Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants
The purpose of this study is to understand if the "DHA gap" can be corrected by giving a daily dose of DHA oil to preterm babies. DHA is an essential omega-3 fatty acid, which means our body cannot make DHA.
- Trial name
- NCT01908907
- Testing
- DHA oil, (MCT) Control oil
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sanford Health
Respiratory Distress Syndrome
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the…
- Trial name
- NCT01709409
- Testing
- Curosurf-Group1, BLES-group 2
- Where
- Canada
- Volunteers
- 88 people
- Sponsor
- Ottawa Hospital Research Institute
13-valent Pneumococcal Vaccine, Premature Birth
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines…
- Conditions
- 13-valent Pneumococcal Vaccine, Premature Birth, Immunization, Safety
- Trial name
- NCT01193335
- Testing
- 13-valent pneumococcal conjugate vaccine
- Where
- 12 sites in Poland, Spain
- Volunteers
- 200 people
- Sponsor
- Pfizer
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Premature Birth of Newborn, Intestinal Malabsorption
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
- Trial name
- NCT02510560
- Testing
- NTRA-2112
- Where
- 50 sites in United States, Belgium and 8 more
- Volunteers
- 300 people
- Sponsor
- Elgan Pharma Ltd.
Respiratory Tract Infection, Respiratory Syncytial Virus
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational…
- Trial name
- NCT03524118
- Testing
- Clesrovimab
- Where
- 34 sites in United States, Chile and 4 more
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prematurity, Apnea
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD).
- Conditions
- Prematurity, Apnea, Respiratory Failure
- Trial name
- NCT01751724
- Testing
- Caffeine citrate, Normal saline
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- University of Miami
Premature Birth, Pregnancy Preterm
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California.
- Conditions
- Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety
- Trial name
- EMBRACE (NCT04154423)
- Testing
- Glow! Group Prenatal Care, Individual Prenatal Care with CPSP
- Where
- 2 sites in United States
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco