Clinical trials: Premature Birth of Newborn
Preterm Birth, Preeclampsia
The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health
The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle…
- Conditions
- Preterm Birth, Preeclampsia, Gestational Diabetes Mellitus (GDM), Small for Gestational Age (SGA)
- Trial name
- ROOT (NCT07559773)
- Testing
- 'Standard of Care PLUS'
- Volunteers
- 500 people
- Sponsor
- GrowBaby Life Project
Retinopathy of Prematurity (ROP)
ROP Check Database Premature Infant Outcomes
The goal of this observation of multi-centered care of infants covered by ROP Check cloud-based database is to compare demographic and clinical risk factors to evaluate and improve vision-protecting guidelines.
- Trial name
- NCT07312669
- Where
- United States
- Volunteers
- 7,070 people
- Sponsor
- Alaska Blind Child Discovery
Cerebral Palsy, Infant, Premature, Diseases
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Premature, Diseases, Infant Development, Neurologic Disorder
- Trial name
- highrisk (NCT05217186)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Bronchopulmonary Dysplasia, Extremely Premature Infants
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies
- Trial name
- NCT01207869
- Testing
- ucMSCs, Normal saline
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
Preeclampsia
Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development
Pregnant mothers who develop high blood pressure and other vascular problems (preeclampsia) deliver babies with increased neonatal health problems, which include lung disease and vascular complications, later in life.
- Trial name
- NCT02639676
- Testing
- Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
- Where
- United States
- Volunteers
- 292 people
- Sponsor
- Indiana University
Drug Safety
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.
- Trial name
- NCT06889376
- Testing
- Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Neonatal Complications
Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth
Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems.
- Trial name
- BETADOSE (NCT02897076)
- Testing
- betamethasone 24 mg
- Where
- France
- Volunteers
- 3,250 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Preterm Infant, Feeding Disorder Neonatal
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility
Mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. We hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before…
- Conditions
- Preterm Infant, Feeding Disorder Neonatal, Gastrointestinal Motility Disorder
- Trial name
- OPAMM (NCT03552510)
- Testing
- Oro-pharyngeal Administration of Mother's Milk
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Mansoura University Children Hospital
Preterm Infants, Neonatal Respiratory Distress Syndrome
Comparison of the Need Of Mechanical Ventilation Between Less Invasive Surfactant Administration (LISA) and Conventional INSURE (Intubation-Surfactant Administration-Extubation) Methods in Spontaneously Breathing Preterm Infants With Respiratory Distress Syndrome
Brief Summary of the Study This randomized controlled trial aims to compare the need for mechanical ventilation between Less Invasive Surfactant Administration (LISA) and the conventional INSURE (Intubation, Surfactant…
- Conditions
- Preterm Infants, Neonatal Respiratory Distress Syndrome, Need for Mechanical Ventilation
- Trial name
- NCT07910539
- Testing
- Intervention Name: Poractant alfa (surfactant) administered by the INSURE method
- Where
- Pakistan
- Volunteers
- 90 people
- Sponsor
- Fatima Jinnah Medical University
Ventilator Lung; Newborn
NIPE as an Indicator of Pain in Sedated/Ventilated Patient Under 3 Years-old Hospitalized in Intensive Care Unit
The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric…
- Trial name
- NIPE (NCT04195672)
- Testing
- NIPE (MDoloris®) and CBS values
- Where
- France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Lille
Premature Birth
E-23596 - Use of NCPAP Cycling to Wean Preterm Infants
Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP) cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation to nasal prongs.
- Trial name
- NCT02114112
- Testing
- NCPAP cycling, NCPAP continuous
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Calgary
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Ultrasonic Diagnosis
Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older Than 32 Weeks
Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free.
- Trial name
- NCT02449863
- Testing
- Lung ultrasound
- Where
- 2 sites in Spain
- Volunteers
- 105 people
- Sponsor
- Hospital Sant Joan de Deu
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Infant, Newborn, Infant, Low Birth Weight
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- FU (NCT00009633)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 68,000 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Premature Rupture of Membrane, Pregnancy, High Risk
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole…
- Conditions
- Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
- Trial name
- NCT06396078
- Testing
- Ceftriaxone 1000 MG, Clarithromycin 500mg, Metronidazole 500 mg
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ohio State University
Newborn Preterm
The Effect of Bed Head Height During Feeding With Orogastric Catheter on Neonatal Growth
Aim:The study was planned as a randomised controlled experimental study to determine the effect of bed head height applied during feeding with orogastric catheter on growth parameters and feeding tolerance of preterm newborns.
- Trial name
- NCT07079878
- Testing
- Group with Bed Head Height 30°, Group with Bed Head Height 45°
- Where
- Turkey (Türkiye)
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Tarsus University
Bottlefeeding, Infant, Premature, Diseases
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and…
- Trial name
- NCT02916914
- Testing
- Q2 feeding
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Premature Infants
Therapeutic Touch in Premature Infants
Preterm birth is associated with increased physiological instability, stress responses, and developmental vulnerability due to immature organ systems and prolonged exposure to invasive procedures and environmental stressors in…
- Trial name
- NCT07363785
- Testing
- Therapeutic Touch
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Selcuk University
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