Clinical trials: Respiratory Control in Premature Infants
Premature Birth of Newborn
Kangaroo Care and Premature Infant Sleep
90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then KC group was placed in KC…
- Trial name
- NCT02473055
- Testing
- Kangaroo Care
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Case Western Reserve University
Respiratory Distress Syndrome, Newborn
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs.
- Trial name
- NCT05399628
- Testing
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter, Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Preterm Infant, Respiratory Insufficiency Syndrome of Newborn
Non-invasive Respiratory Support in Preterm Infants
Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe.
- Conditions
- Preterm Infant, Respiratory Insufficiency Syndrome of Newborn, Bronchopulmonary Dysplasia
- Trial name
- NOVEL (NCT03512158)
- Testing
- Non-invasive respiratory support mode
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McMaster Children's Hospital
Bronchopulmonary Dysplasia
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants.
- Trial name
- PREMILOC (NCT00623740)
- Testing
- hydrocortisone
- Where
- France
- Volunteers
- 523 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Newborn Morbidity, Respiratory Failure
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured.
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Trial name
- NCT04191239
- Testing
- GE ventilator with two different modes
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Ankara City Hospital Bilkent
Invasive Ventilation, Infant Pain
Dexmedetomidine for Invasive Ventilation In the NEOnate
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment
- Trial name
- NCT07493785
- Testing
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Where
- 12 sites in France
- Volunteers
- 246 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Infant,Premature
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
- Trial name
- NCT03333174
- Testing
- Cardiorespiratory monitoring
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Pain, Infant, Premature, Diseases
Continuous Infusion of Fentanyl in Preterm on MV
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV: Group A) continuous…
- Conditions
- Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
- Trial name
- NCT00571636
- Testing
- Fentanyl, 5% glucose solution
- Where
- Italy
- Volunteers
- 128 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Apnea of Prematurity
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after…
- Trial name
- MoCHA (NCT03340727)
- Testing
- Caffeine Citrate
- Where
- 16 sites in United States
- Volunteers
- 827 people
- Sponsor
- NICHD Neonatal Research Network
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Bronchopulmonary Dysplasia, Chronic Pulmonary Insufficiency of Prematurity
Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial
This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS.
- Trial name
- LateRecSurf (NCT04825197)
- Testing
- Poractant Alfa Intratracheal Suspension [Curosurf]
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- VENTO GIOVANNI
Respiratory Distress Syndrome, Newborn, Infant, Premature
Neural Control of Non-invasive Ventilation in the Preterm
The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing muscle - to control the timing…
- Trial name
- NCT00368485
- Testing
- Neurally Controlled Mechanical Ventilation
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Preterm Birth, Caffeine
Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support
The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing.
- Conditions
- Preterm Birth, Caffeine, Neonatal Outcomes
- Trial name
- CARES-Pilot (NCT07456670)
- Testing
- Caffeine
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Queen's University
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
Bronchopulmonary Dysplasia
Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings.
- Trial name
- NCT05777512
- Testing
- Gastric Feeds, Jejunal Feeds
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Children's Hospital
Severe Bronchopulmonary Dysplasia
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants.
- Trial name
- NCT03392467
- Testing
- PNEUMOSTEM
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.