Clinical trials: Neonates and Preterm Infants, open to volunteers
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Preterm Birth Complication, Preterm Birth
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
The goal of this clinical trial is to learn if a personalized prenatal support program [(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)] works to…
- Conditions
- Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia
- Trial name
- PTBCARE+ (NCT06915428)
- Testing
- Care coordination, Electronic massage, support gift #1
- Where
- United States
- Volunteers
- 1,228 people
- Sponsor
- University of North Carolina, Chapel Hill
Bronchopulmonary Dysplasia (BPD)
Continued Pressure for Alveolar Protection (CPAP Trial)
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at…
- Trial name
- CPAP (NCT07417111)
- Testing
- CPAP, Nasal Cannula
- Where
- 15 sites in United States
- Volunteers
- 860 people
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Swiss Neonatal Network & Follow-up Group
The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- Trial name
- SwissNeoNet (NCT04239508)
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Swiss Neonatal Network
Respiratory Distress Syndrome, Newborn
LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
This prospective, non-randomized, unblinded pilot study evaluates and compares the intrapulmonary distribution of exogenous surfactant in preterm neonates when administered via Less Invasive Surfactant Administration (LISA)…
- Trial name
- LISA-Ven-LUS (NCT07514481)
- Testing
- surfactant administration by ETT, surfactant administration by thin catheter
- Where
- Qatar
- Volunteers
- 22 people
- Sponsor
- Hamad General Hospital
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Retinopathy of Prematurity (ROP), Prematurity Complications
Retinopathy of Prematurity - Visual Function and Retinal Structure
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness.
- Conditions
- Retinopathy of Prematurity (ROP), Prematurity Complications, Cerebral Visual Impairment, Visual Field Defect
- Trial name
- NCT07427719
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- Oslo University Hospital
Mental Health Wellness 1, Premature Birth
Fathers and Partners in Family Integrated Care Study
AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge.
- Trial name
- TARGET (NCT06022991)
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Homerton University Hospital NHS Foundation Trust
Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of…
- Trial name
- NCT04218318
- Testing
- phototherapy
- Where
- Saudi Arabia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
BPD - Bronchopulmonary Dysplasia
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants
Bronchopulmonary dysplasia (BPD) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants.
- Trial name
- MSC，BPD (NCT06788470)
- Testing
- MSC
- Where
- China
- Volunteers
- 10 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Prematurity, Respiratory Disease
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and…
- Conditions
- Prematurity, Respiratory Disease, Ventilator Lung; Newborn
- Trial name
- CAT/LPT (NCT06026163)
- Testing
- Caffeine citrate
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 134 people
- Sponsor
- Ministry of Health, Saudi Arabia
Neonatal Respiratory Failure
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange.
- Trial name
- Flow&Grow (NCT06123143)
- Testing
- Standardized/structured CPAP weaning protocol
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- University of California, San Diego
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Preterm Birth
The Social Determinants of Health Screening and Referral Project
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH).
- Trial name
- NCT06582147
- Testing
- Implementation of social determinants of health screening and referral
- Where
- 7 sites in United States
- Volunteers
- 882 people
- Sponsor
- University of Massachusetts, Worcester
Infant, Premature, Intubation, Intratracheal
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen…
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Trial name
- NEORIN (NCT07650552)
- Testing
- Rocuronium Bromide 10 MG/ML, Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- UEA - Universidade Do Estado Do Amazonas
Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication
Parent Perceptions of OptiPAP Junior
To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication, Pulmonary, CPAP
- Trial name
- NCT07837700
- Testing
- Nasal CPAP interface: OptiPAP Junior, Nasal CPAP interface: FlexiTrunk
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Sharp HealthCare
Extubation Failure, Bronchopulmonary Dysplasia
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted…
- Conditions
- Extubation Failure, Bronchopulmonary Dysplasia, Death
- Trial name
- DIVA (NCT05446272)
- Testing
- NIV-NAVA, NS-NIPPV
- Where
- 20 sites in United States, Canada
- Volunteers
- 478 people
- Sponsor
- University of Pennsylvania
Extreme Prematurity, Anemia of Prematurity
Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants.
- Trial name
- FASCINATE (NCT06220461)
- Testing
- Folic acid
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Calgary