Clinical trials: Birth, Preterm
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Obstetric Labour, Premature
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
This study in healthy, adult Japanese women will characterize the PK, safety and tolerability of retosiban at the therapeutic doses planned to be evaluated in Phase 3.
- Trial name
- NCT02377414
- Testing
- Retosiban solution for Infusion
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who…
- Trial name
- NCT01146990
- Testing
- ASQ-3, Bayley III, Neurologic exam
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 245 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Preterm Birth
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34…
- Trial name
- PCP002 (NCT02225353)
- Testing
- Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, Progesterone Cervical Pessary 7.7 g
- Where
- 4 sites in Chile
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Preterm Labor, PreTerm Birth
Electrical Inhibition of Human Preterm Contractions
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration…
- Conditions
- Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
- Trial name
- NCT02983240
- Testing
- Electrical Uterine Pacemaker
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- e-Bio Corp
Cognitive Developmental Delay
Neurocognitive Follow-Up (FU) Study
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
- Trial name
- NCT04962035
- Testing
- Neurocognitive Follow-up
- Where
- 3 sites in Poland, Slovakia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant, Premature, Nutrition
Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants.
- Trial name
- NCT03055052
- Testing
- Standard formula for preterm infants, Formula with higher protein and new fat blend for preterm infants
- Where
- Vietnam
- Volunteers
- 160 people
- Sponsor
- Société des Produits Nestlé (SPN)
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
Weight Gain
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF…
- Trial name
- NCT03604042
- Testing
- Protein fortifier
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Société des Produits Nestlé (SPN)
Intestinal Malabsorption
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
- Trial name
- NCT05904626
- Testing
- ELGN-2112
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Elgan Pharma Ltd.
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
sFlt1 Mediated Preterm Preeclampsia, Preeclampsia
A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months
This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant…
- Conditions
- sFlt1 Mediated Preterm Preeclampsia, Preeclampsia, Preterm Preeclampsia
- Trial name
- NCT07282171
- Testing
- CBP-4888
- Where
- 3 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Comanche Biopharma
Other Preterm Infants
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
This is a two stage open-label, single-arm, multicenter and observational study.
- Trial name
- NCT02073071
- Testing
- Preterm infant formula per standard of care
- Where
- 10 sites in China
- Volunteers
- 139 people
- Sponsor
- Abbott Nutrition
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Obstetric Labour, Premature, Premature Ejaculation
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00449709
- Testing
- GSK221149
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preeclampsia
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
- Trial name
- SAVE (NCT02923206)
- Testing
- TheraSorb sFlt-1 adsorber
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Miltenyi Biomedicine GmbH
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP