Clinical trials: Preterm Neonate
Apnea of Prematurity, Intermittent Hypoxemia
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose).
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bronchopulmonary Dysplasia of Newborn
- Trial name
- STRAP (NCT07895654)
- Testing
- Chinstrap
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Infant, Newborn, Respiratory Insufficiency
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of hypoxemic respiratory failure in term newborns.
- Conditions
- Infant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
- Trial name
- IPGE1 (NCT00598429)
- Testing
- Inhaled Prostaglandin E1
- Where
- 11 sites in United States
- Sponsor
- NICHD Neonatal Research Network
Cerebral Disorders Congenital, Premature Birth
Italian Survey on Paediatric and Neonatal MRI
Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this…
- Trial name
- NCT04775641
- Testing
- questionnaire
- Where
- Italy
- Volunteers
- 876 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prematurity, Vascular Aging
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.
- Trial name
- NEOVASC (NCT04413994)
- Testing
- Humavant
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Prolacta Bioscience
Infant, Premature, Diseases
The Effect of Diaper Change Position on Preterm Infants
The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.
- Trial name
- NCT04528602
- Testing
- Control (Extended leg position) Group, Experimental (Legs are flexed toward abdomen) Group
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Acibadem University
Enteral Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum for Preterm Newborns
Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN).
- Conditions
- Enteral Feeding Intolerance, Necrotizing Enterocolitis, Late-Onset Neonatal Sepsis
- Trial name
- PreColos-RCT (NCT03085277)
- Testing
- Bovine Colostrum, Preterm Formula
- Where
- 8 sites in China
- Volunteers
- 350 people
- Sponsor
- Per Torp Sangild
Retinopathy of Prematurity
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.
- Trial name
- SAT01ROP (NCT00845624)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Infant, Premature, Diseases
Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
- Trial name
- NCT01731613
- Testing
- human milk fortifier
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Peking Union Medical College Hospital
Respiratory Distress Syndrome (RDS), Infant, Premature, Diseases
FiO2 Delivered With Neonatal bCPAP
Continuous positive airway pressure (CPAP) is the mainstay of treatment recommended for preterm infants with respiratory distress syndrome in all resource contexts.
- Conditions
- Respiratory Distress Syndrome (RDS), Infant, Premature, Diseases, Infant, Newborn, Diseases
- Trial name
- NCT06615427
- Where
- Vietnam
- Volunteers
- 100 people
- Sponsor
- Karolinska Institutet
Pain, Fever
Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates
The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv bolus paracetamol), document multiple dose…
- Trial name
- PARANEO (NCT00969176)
- Testing
- paracetamol
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Periventricular Leukomalacia
Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy
Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral ventricles of the brain occurring in the prenatal period, associated with a disorder of movement and posture, known as bilateral cerebral palsy.
- Trial name
- NCT02342990
- Testing
- Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit, Cluster A No training. Delay start of CogMed
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- IRCCS Fondazione Stella Maris
Bronchopulmonary Dysplasia, Child Development
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- MOBYDIck (NCT02371460)
- Testing
- DHA-rich algal oil
- Where
- 16 sites in Canada
- Volunteers
- 461 people
- Sponsor
- CHU de Quebec-Universite Laval
Infant, Premature, Diseases, Motor Development
Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
- Trial name
- NCT04889027
- Testing
- Standardized Infant NeuroDevelopmental Assessment
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Ondokuz Mayıs University
Anemia
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in…
- Trial name
- NCT02103296
- Testing
- Drawing admission labs from cord blood, Drawing admission labs from infant blood
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- Capt Alicia Prescott
Necrotizing Enterocolitis, Enterocolitis, Necrotizing
Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis
Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies.
- Trial name
- NCT02796703
- Testing
- Heat Inactivated probiotics
- Where
- Israel
- Volunteers
- 450 people
- Sponsor
- Shaare Zedek Medical Center
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute
Duration of Parenteral Nutrition
Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and…
- Trial name
- NCT00290576
- Testing
- Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
- Where
- France
- Volunteers
- 127 people
- Sponsor
- Nantes University Hospital
Nutrition Disorders, Gastrointestinal Disease
Review of Infant Oral Feeding and Skills
This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral…
- Conditions
- Nutrition Disorders, Gastrointestinal Disease, Deglutition Disorder, Feeding Difficulties
- Trial name
- RIOS (NCT06736743)
- Testing
- SMART Tool for Feeding Skill Assessment
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wake Forest University Health Sciences
Bronchopulmonary Dysplasia, Lung Diseases
Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project)
To investigate risk factors in bronchopulmonary dysplasia (BPD) and to elucidate the relationship between BPD, acute lung disease severity, respiration-related variables, water balance, nutrition, familial predisposition, and…
- Conditions
- Bronchopulmonary Dysplasia, Lung Diseases, Respiratory Distress Syndrome
- Trial name
- NCT00005289
- Volunteers
- 2,202 people
- Sponsor
- University of Wisconsin, Madison
Bronchopulmonary Dysplasia, Vitamin D Overdose
25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death
Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an…
- Trial name
- 25OHVDORBPDD (NCT05944055)
- Testing
- Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?
- Where
- France
- Volunteers
- 173 people
- Sponsor
- Hospices Civils de Lyon
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