Clinical trials: Premature Birth of Newborn
Fathers, Premature Birth
Study on the Treatment of Children and Their Families in Services Related to Early Childhood
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units.
- Trial name
- PERAM-QUAL (NCT02201433)
- Where
- 2 sites in France
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Infant, Premature, Diseases, Infant, Newborn, Diseases
Pulmonary Function Using Non-invasive Forced Oscillometry
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn
- Trial name
- PUFFOR (NCT03346343)
- Testing
- Non-invasive forced airway oscillometry
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Newborn
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
- Trial name
- NCT01102543
- Where
- France
- Volunteers
- 972 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Disorders
Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates
The aim of the study is to compare the non-inferiority of the Mix-safe T-piece resuscitator (intervention group) to the Neopuff T-piece resuscitator (control group) in providing respiratory assistance during the resuscitation of…
- Trial name
- NCT07422116
- Testing
- Mixsafe T piece resucitator, Standardized T Piece resuscitator
- Where
- Indonesia
- Volunteers
- 107 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Hyaline Membrane Disease
MISurf Versus InSurE. A Comparison of Minimally Invasive Surfactant Application Techniques in Preterm Infants
The lungs of infants born too early are extremely underdeveloped. Respiratory Distress Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks early and leads to the collapse of their lungs.
- Trial name
- MIsurf (NCT01615016)
- Testing
- Minimally invasive endotracheal surfactant application
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- Hamilton Health Sciences Corporation
Serious Systemic Infections, Necrotizing Enterocolitis
Metronidazole Pharmacokinetics (PK) in Premature Infants
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis.
- Trial name
- PTN_METRO (NCT01222585)
- Testing
- Metronidazole
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Michael Cohen-Wolkowiez
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Bronchopulmonary Dysplasia
MRI in BPD Subjects
The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)
- Trial name
- NCT03657693
- Testing
- NICU MRI, Polysomnography
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal SEPSIS, Prematurity
Neonatal Bacterial Colonization Study
This study will evaluate the effect of skin antisepsis and/or emollient therapy on bacterial colonization dynamics in very low birth weight, hospitalized infants.
- Conditions
- Neonatal SEPSIS, Prematurity, Very Low Birth Weight Baby, Bloodstream Infection
- Trial name
- NCT03896893
- Testing
- Skin antisepsis, Emollient
- Where
- South Africa
- Volunteers
- 80 people
- Sponsor
- University of Stellenbosch
Prenatal Care
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning.
- Trial name
- NCT02330887
- Testing
- Group Antenatal Care, Individual Antenatal Care
- Where
- Nepal
- Volunteers
- 2,184 people, healthy volunteers welcome
- Sponsor
- Possible
Infant, Premature, Bronchopulmonary Dysplasia
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature <32 weeks gestation to infants born full term >37 weeks.
- Conditions
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- Trial name
- NCT00428038
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Indiana University
Preterm Birth, Bronchopulmonary Dysplasia
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the urea cycle-nitric oxide pathway…
- Conditions
- Preterm Birth, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- IMPROV (NCT01460576)
- Where
- 2 sites in United States
- Volunteers
- 253 people
- Sponsor
- Vanderbilt University Medical Center
Sepsis, Bronchopulmonary Dysplasia
Cysteine Supplementation in Critically Ill Neonates
Critically ill babies less than 1 month of age have deficient amounts of the antioxidant glutathione and a high incidence of disease associated with oxidative injury compared to healthy babies.
- Conditions
- Sepsis, Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Retinopathy of Prematurity
- Trial name
- NCT00254176
- Testing
- Parenteral cysteine-HCl supplementation
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- University of California, Los Angeles
Chronic Lung Disease, Bronchopulmonary Dysplasia
Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease
Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major complication of premature birth and is associated with a significant increased risk of complications including death.
- Trial name
- NCT01721655
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- West Virginia University Healthcare
Premature Birth of Newborn
The Adding Value of Parents to Nursing Care in the Control of FiO2
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at…
- Trial name
- NCT02306317
- Testing
- Standard procedure, Experimental procedure
- Where
- Spain
- Volunteers
- 46 people
- Sponsor
- Carmen Rosa Pallas
Bronchopulmonary Dysplasia (BPD)
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
Extreme preterm infants (GA ≤ 28+6 weeks) are at high risk for bronchopulmonary dysplasia (BPD) that has been associated with significant long-term impairment.
- Trial name
- NCT04756297
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Adel Mohamed
Neonatal Respiratory Distress Syndrome
Flow-cycled Ventilation in Preterm Infants
This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants require less overall pressure from the…
- Trial name
- FLIPI (NCT02522455)
- Testing
- Flow-cycle ventilation, Time-cycle ventilation mode
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Manchester University NHS Foundation Trust
Bronchopulmonary Dysplasia, Premature
THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA
The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.
- Conditions
- Bronchopulmonary Dysplasia, Premature, Ventilation, Mechanical
- Trial name
- NCT06584474
- Testing
- Azithromycin neubilization, Lung ultrasound
- Where
- 2 sites in Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Early-Onset Neonatal Sepsis
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis…
- Trial name
- PROPOSE (NCT05796115)
- Testing
- Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS, Antibiotic prophylaxis for EOS
- Volunteers
- 266 people
- Sponsor
- University of Florence
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