Clinical trials: Birth, Preterm
Respiratory Distress Syndrome
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus.
- Trial name
- NCT01812681
- Where
- Turkey (Türkiye)
- Volunteers
- 81 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or…
- Trial name
- NCT03576885
- Testing
- inhaled nitric oxide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Anesthesia
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks…
- Trial name
- NCT01508455
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Preterm Delivery
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1.
- Trial name
- 17PinPROM (NCT01119963)
- Testing
- 17-alpha-hydroxy-progesterone caproate, Makena®
- Where
- 15 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Preeclampsia
Low Doses of Aspirin in the Prevention of Preeclampsia
Preeclampsia (PE) is a morbid and potentially lethal complication of pregnancy and is more common in women with specific risk factors.
- Trial name
- ASAPP (NCT04070573)
- Testing
- acetylsalicylic acid
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Weill Medical College of Cornell University
Premature Birth
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi.
- Trial name
- NCT03673709
- Testing
- Antenatal Care
- Where
- 7 sites in Malawi
- Volunteers
- 1,887 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics
Infant,Premature, Respiratory Failure
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD.
- Conditions
- Infant,Premature, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT03558737
- Testing
- Nasal high-frequency jet ventilation (nHFJV), Nasal intermittent positive pressure ventilation (NIPPV)
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- University of Utah
Preterm Infants
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit…
- Trial name
- NCT03370757
- Testing
- 3-hour bundled care, 6-hour bundled care
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke University
Prematurity, Respiratory Distress Syndrome
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal…
- Trial name
- NCT00821119
- Testing
- nasal intermittent positive pressure ventilation
- Where
- 2 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Prematurity, Necrotizing Enterocolitis
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants.
- Trial name
- NCT01106209
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Utah
Preterm Birth
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine…
- Trial name
- NCT00212446
- Testing
- Electrical Intervention (EI)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center