Clinical trials: Premature Neonates
Cerebral Palsy, Perinatal Stroke
Single-session tDCS in Cerebral Palsy
The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration…
- Conditions
- Cerebral Palsy, Perinatal Stroke, Periventricular Leukomalacia
- Trial name
- NCT03635775
- Testing
- Active tDCS
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Bronchopulmonary Dysplasia
Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD
Patients will be randomized to begin the study with either NAVA-synchronized or continuous HFNC. Each patient will receive two 15-minute trials at different levels of continuous HFNC and two 15-minute trials at corresponding…
- Trial name
- NCT04274192
- Testing
- Synchronized HFNC at 6 liters per minute (LPM), Continuous HFNC at 6 liters per minute (LPM), Synchronized HFNC at 8 liters per minute (LPM)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Arkansas
Skin Disorder
Characterization of Pre-Term Neonatal Skin
The skin of pre-term neonates is not fully developed and often leads to trans-epidermal water loss, trouble regulating temperature, and increased risk of skin wounds.
- Trial name
- NCT05127044
- Testing
- Diffuse Reflectance Spectroscopy, BiliChek
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
Pulmonary Infections
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic…
- Trial name
- PVAIN (NCT01356147)
- Testing
- Dornase alfa
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
Bronchopulmonary Dysplasia
Trial II of Lung Protection With Azithromycin in the Preterm Infant
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
- Trial name
- NCT00319956
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Hubert Ballard
Hypothermia
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming…
- Trial name
- NCT00603837
- Testing
- NeoWrap, InfaTherm
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
NHFOV as Primary Support in Very Preterm Infants With RDS
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China.
- Trial name
- NCT05141435
- Testing
- infants receive primary non-invasive respiratory support by mean of nCPAP, infants receive primary non-invasive respiratory support by mean of NHFOV
- Where
- 3 sites in China
- Volunteers
- 360 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Upper Extremity Dysfunction
Movement Enhancing Device for Children
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk…
- Trial name
- NCT01959581
- Testing
- Movement Enhancing Device
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Premature Birth
Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
Women recruited from the internet will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information on the likelihood of survival and chance of disability for babies born at this…
- Trial name
- NCT04859114
- Testing
- Format of outcome data presentation, Displayed chance of survival
- Where
- United States
- Volunteers
- 1,052 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Bronchopulmonary Dysplasia
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
This study will describe the safety of furosemide in premature infants at risk of bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics (PK) of furosemide. Funding Source - FDA OOPD
- Trial name
- NCT02527798
- Testing
- Furosemide Cohort 1, Furosemide Cohort 2, Furosemide Cohort 3
- Where
- 21 sites in United States
- Volunteers
- 82 people
- Sponsor
- University of North Carolina, Chapel Hill
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Preterm Infants
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements.
- Trial name
- NCT01235923
- Testing
- three times weekly Epo, weekly Epo
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of New Mexico
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston
Pre-Eclampsia, Pre-Term
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease.
- Conditions
- Pre-Eclampsia, Pre-Term, Intrauterine Growth Restriction, Hypertension in Pregnancy
- Trial name
- VIA (NCT04633551)
- Testing
- Anti-inflammatory supplement
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Preterm Labor, Tobacco Use Disorder
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications.
- Trial name
- INFANTS (NCT04417595)
- Testing
- Fish Oil (Containing Omega-3 Acids), Olive Oil
- Where
- United States
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Respiratory Distress Syndrome, Newborn
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the…
- Trial name
- NCT02452476
- Testing
- CHF5633, Poractant alfa
- Where
- 23 sites in United States
- Volunteers
- 123 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one…
- Trial name
- Fenaki (NCT02620761)
- Testing
- Fenoldopam, 0.9%NS
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
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