Clinical trials: Respiratory Control in Premature Infants
Pre-Term, Respiratory Distress Syndrome, Newborn
NeO2Matic-Pilot Trial
The main goal of this trial is to test if: automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation results in more stable…
- Conditions
- Pre-Term, Respiratory Distress Syndrome, Newborn, Retinopathy of Prematurity, Bronchopulmonary Dysplasia
- Trial name
- NEO2MATIC (NCT05629910)
- Testing
- O2Matic
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Respiratory Distress Syndrome, Newborn
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo…
- Trial name
- NCT00139256
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Emory University
Preterm Infant
NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome
This will be a prospective, multi-center, three-arms,parallel, randomized, controlled trial with a superiority design,conducted in China.
- Trial name
- NCT03842462
- Testing
- nCPAP, NIPPV, NHFOV
- Where
- 8 sites in China
- Volunteers
- 684 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Preterm, Respiratory Distress Syndrome in Premature Infant
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory…
- Conditions
- Preterm, Respiratory Distress Syndrome in Premature Infant, Recruitment, Mechanical Ventilation
- Trial name
- NCT07896824
- Testing
- Superimposed sigh breaths, High frequency ventilation
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Hyaline Membrane Disease, Transient Tachypnea
Antenatal Corticoid Therapy for Late Preterm Babies
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of…
- Trial name
- ACTLPT (NCT00675246)
- Testing
- Betamethasone
- Where
- Brazil
- Volunteers
- 320 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Bronchopulmonary Dysplasia (BPD), Prematurity
Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
- Trial name
- VITA-BPD (NCT07577180)
- Testing
- Vitamin A
- Where
- Turkey (Türkiye)
- Volunteers
- 209 people
- Sponsor
- Erhan Calisici
Kangaroo-Mother Care, Preterm Infants
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams…
- Trial name
- NCT06707376
- Testing
- Early Kangaroo Mother Care
- Where
- Egypt
- Volunteers
- 240 people
- Sponsor
- Jouf University
Bronchopulmonary Dysplasia
Preservation of Blood in Extremely Preterm Infants
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine.
- Trial name
- LIM (NCT04239690)
- Testing
- Micromethods for blood sample analysis
- Where
- Sweden
- Volunteers
- 201 people
- Sponsor
- David Ley
RSV Infections, RSV Immunisation
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too…
- Conditions
- RSV Infections, RSV Immunisation, Preterm Labour
- Trial name
- NCT06955728
- Testing
- Vaccine
- Where
- 11 sites in Ghana, Kenya and 2 more
- Volunteers
- 13,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Transient Tachypnea of the Newborn
Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.
- Trial name
- NCT01858129
- Testing
- Experimental group: Budicort by Inhalation
- Where
- Israel
- Volunteers
- 56 people
- Sponsor
- Bnai Zion Medical Center
Bronchopulmonary Dysplasia
p16Ink4a in Bronchopulmonary Dysplasia in Children
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure.
- Trial name
- DBP16 (NCT03540680)
- Testing
- Blood punction
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Complication Due to Immunization
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
- Trial name
- NCT02726178
- Testing
- Advil® Pediatric drops for infants
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
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
Bronchopulmonary Dysplasia
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this…
- Trial name
- GENBPD (NCT00904774)
- Where
- France
- Volunteers
- 800 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Pre-Term, Respiratory Disease
Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism.
- Trial name
- NCT05017727
- Testing
- Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- King's College Hospital NHS Trust
Respiratory Distress Syndrome
ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT
Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory…
- Trial name
- ECALMIST (NCT01848262)
- Testing
- ECALMIST, InSure
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- University of Manitoba
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca