Clinical trials: Premature; Infant
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two…
- Trial name
- NCT02249143
- Testing
- CPAP and room air
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Oregon Health and Science University
Hypoxia
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of…
- Trial name
- NCT01875159
- Testing
- Caffeine citrate 6 mg/kg/day
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- American SIDS Institute
Bronchopulmonary Dysplasia
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs.
- Trial name
- NCT00955487
- Testing
- Inhaled Nitric Oxide (iNO)
- Where
- 6 sites in United States
- Volunteers
- 124 people
- Sponsor
- University of Colorado, Denver
Retinopathy of Prematurity
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP.
- Trial name
- SPIPROP (NCT02344225)
- Testing
- Caffeine citrate, Ibuprofen, Ketorolac
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- State University of New York - Downstate Medical Center
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation.
- Trial name
- NCT01727505
- Testing
- Sequence A: Conventional-Volume Guarantee, Sequence B: Volume Guarantee-Conventional
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
Bacteria Infection, Respiratory Tract Infections
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection…
- Trial name
- NCT00599053
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Alabama at Birmingham
Cerebral Palsy, Prematurity
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered…
- Conditions
- Cerebral Palsy, Prematurity, Early Intervention, Family Centered Care
- Trial name
- NCT04330859
- Testing
- NeoRehab Bundle, Routine care
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Virginia
Very Premature Baby
Attention Control Training (ACT) and Very Preterm Infants
Infants' attention control, defined as the ability to select what to pay attention to, is a fundamental building block for developing learning abilities and behaviour self-regulation.
- Trial name
- ACT (NCT03896490)
- Testing
- Attention Control Training, Control
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Queen's University, Belfast
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
GERD
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
- Trial name
- NCT00427635
- Testing
- Esomeprazole
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Respiratory Distress Syndrome
Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS
Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant).
- Trial name
- ECALMIST (NCT01553292)
- Testing
- ECALMIST
- Where
- 3 sites in Canada
- Volunteers
- 21 people
- Sponsor
- University of Manitoba
Retinopathy of Prematurity
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of…
- Trial name
- NCT01238471
- Testing
- propranolol, sucrose 5%
- Where
- 4 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Rambam Health Care Campus
Bronchopulmonary Dysplasia (BPD)
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
- Trial name
- SASSIE (NCT02907593)
- Testing
- Budesonide in Calfactant
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cynthia McEvoy
Respiratory Compliance, Functional Residual Capacity
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems.
- Conditions
- Respiratory Compliance, Functional Residual Capacity, Pulmonary Function Testing
- Trial name
- NCT00669383
- Testing
- betamethasone
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
Breastfeeding
Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns
The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns.
- Trial name
- NCT00930761
- Testing
- Music therapy
- Where
- Brazil
- Volunteers
- 101 people
- Sponsor
- Universidade Federal do Rio de Janeiro
Infant Apnea, Neonatal Abstinence Syndrome
Interventions to Help Infants Recover in the Hospital
This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological…
- Conditions
- Infant Apnea, Neonatal Abstinence Syndrome, Sleep
- Trial name
- NCT03881553
- Testing
- NEATCAP, SVS mattress
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Elisabeth Salisbury, PhD
Respiratory Distress Syndrome, Newborn
ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory distress syndrome (RDS) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants.
- Trial name
- NCT04137783
- Testing
- no intervention
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Children's Hospital of Chongqing Medical University