Clinical trials: Premature Neonates
Preterm Birth, Preterm Labor
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth).
- Conditions
- Preterm Birth, Preterm Labor, Multiple; Pregnancy, Complicated, Twin Dichorionic Diamniotic Placenta
- Trial name
- SPRUCE (NCT06053697)
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Liverpool
Preterm Birth
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm…
- Trial name
- 170HP (NCT00163020)
- Testing
- 17-alpha-hydroxyprogesterone caproate injectable
- Where
- 18 sites in United States
- Volunteers
- 321 people
- Sponsor
- Obstetrix Medical Group
Pathology of Pregnancy
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.
- Trial name
- ICAR (NCT01610258)
- Testing
- Blood and placenta samples
- Where
- 2 sites in France
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Neonatal Temperature; Kangaroo Mother Care
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).
- Trial name
- NCT02645526
- Testing
- Woolen cap
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University Hospital Padova
Newborn Morbidity, Oxidative Stress
Antioxidant Effects of Melatonin in Preterm
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals.
- Conditions
- Newborn Morbidity, Oxidative Stress, Pre-Term, Melatonin Deficiency
- Trial name
- NCT04785183
- Testing
- Melatonin drops
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Fetal Infection, Chorioamnionitis
Management of Prelabor Rupture of the Membranes at Term
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is…
- Conditions
- Fetal Infection, Chorioamnionitis, Endometritis, Cesarean Section Complications
- Trial name
- NCT04307069
- Testing
- Oxytocin
- Where
- Israel
- Volunteers
- 524 people
- Sponsor
- Rambam Health Care Campus
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
Retinopathy of Prematurity
Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1
The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby, it's characterized for proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.
- Trial name
- Bevacizumab (NCT02090322)
- Testing
- Injection of bevacizumab intravitreal (Avastin)
- Where
- 3 sites in Mexico
- Volunteers
- 60 people
- Sponsor
- Universidad Autonoma de San Luis Potosí
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Premature Birth, Obstetric Labor, Premature
Family Nurture Intervention in the NICU
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal…
- Trial name
- NCT02710474
- Testing
- Family Nurture Intervention, Standard Care
- Where
- 2 sites in United States
- Volunteers
- 461 people
- Sponsor
- Columbia University
Neonatal Sepsis
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.
- Trial name
- NCT04474327
- Testing
- Montelukast Sodium
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Mansoura University Children Hospital
Infant Respiratory Distress Syndrome, Ventilator Lung; Newborn
Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants
Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or…
- Trial name
- CLAC-4 (NCT03163108)
- Testing
- Closed-loop automatic oxygen control (CLAC) fast in addition to RMC, Closed-loop automatic oxygen control (CLAC) slow in addition to RMC
- Where
- 2 sites in Germany
- Volunteers
- 19 people
- Sponsor
- University Hospital Tuebingen
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Anti-MERS-CoV Convalescent Plasma Therapy
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.
- Trial name
- NCT02190799
- Testing
- Convalescent plasma
- Where
- Saudi Arabia
- Sponsor
- King Abdullah International Medical Research Center
Necrotizing Enterocolitis
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.
- Trial name
- NCT03700957
- Testing
- Docosahexaenoic Acid
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Bronchopulmonary Dysplasia (BPD)
Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia
The goal of this clinical trial is to learn if budesonide works to prevent bronchopulmonary dysplasia in newborn less than 32 weeks gestational age or birth weight less than 1500 g with respiratory distress syndrome who needs…
- Trial name
- NCT07725575
- Testing
- Experimental
- Where
- Indonesia
- Volunteers
- 86 people
- Sponsor
- Universitas Indonesia
Transient Tachypnea of the Newborn
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality…
- Trial name
- NCT01270581
- Testing
- High Flow Nasal Cannula, Bubble Nasal CPAP
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS).
- Conditions
- Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure, Neonate
- Trial name
- NCT04905732
- Testing
- NHFOV, NCPAP
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Respiratory Distress Syndrome, Newborn
Infant Respiratory Interface and Accessories Evaluation Study
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
- Trial name
- NCT05719298
- Testing
- Respiratory interface
- Where
- Australia
- Volunteers
- 150 people
- Sponsor
- Fisher and Paykel Healthcare
Metabolic Bone Disease, Osteopenia
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature…
- Conditions
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- Trial name
- NCT04752098
- Testing
- Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Mayo Clinic
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