Clinical trials: Infant, Extremely Premature
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial…
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- SAVE (NCT00005777)
- Testing
- Minimal mechanical ventilation management, Routine mechanical ventilation management, Dexamethasone
- Where
- 13 sites in United States
- Volunteers
- 220 people
- Sponsor
- NICHD Neonatal Research Network
Premature Infant, Ventilation Therapy
High Flow Nasal Cannula for Stabilization of Extremely Premature Infants
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth.
- Conditions
- Premature Infant, Ventilation Therapy, High Flow Nasal Canula
- Trial name
- SIMPLSAFE2 (NCT06683677)
- Testing
- High-Flow Nasal Cannula
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic
Prematurity; Extreme, Feeding Patterns
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
- Conditions
- Prematurity; Extreme, Feeding Patterns, Ventilator Lung; Newborn
- Trial name
- NCT05824377
- Testing
- Continuous Feeds, Intermittent Bolus Feeds
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Rajeev Kumar
Prematurity; Extreme
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during…
- Trial name
- NCT05615311
- Testing
- Vitamin D supplementation, No additional vitamin D supplementation
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- University of Alabama at Birmingham
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Infant, Newborn, Infant, Low Birth Weight
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- MgSO4 (NCT01203501)
- Where
- 15 sites in United States
- Volunteers
- 1,339 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity, Premature Birth
Vibroacoustic Study of Lung Development in Newborn Infants
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.
- Conditions
- Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme
- Trial name
- NCT05827250
- Testing
- imPulse Tor
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Level 42 AI, Inc.
Premature Infants, Near-infrared Spectroscopy
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the…
- Conditions
- Premature Infants, Near-infrared Spectroscopy, Oximetry
- Trial name
- SafeBoosC-p (NCT01530360)
- Testing
- cerebral oximeter
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Gorm Greisen
Very Preterm and Extremely Preterm Birth, Anemia
Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respect to HAS 2014 Recommendations
Prematurity affects around 60,000 births a year in France. Extremely premature babies are particularly fragile and require multiple erythrocyte transfusions to maintain an effective hemoglobin level for metabolism and continued…
- Conditions
- Very Preterm and Extremely Preterm Birth, Anemia, Erythrocyte Transfusion, Excess Transfusion
- Trial name
- CGR EXCESS (NCT06909487)
- Where
- France
- Volunteers
- 201 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
ELGAN (22-28SA), Extremely Low Gestational Age Newborns
Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly.
- Conditions
- ELGAN (22-28SA), Extremely Low Gestational Age Newborns, Cardiovascular Immaturity
- Trial name
- ELGAN AMINES (NCT06737965)
- Testing
- Medical abortion, Foetopathology exam, Outcomes mesurement
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Montpellier
Extreme Prematurity, Anemia of Prematurity
Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants.
- Trial name
- FASCINATE (NCT06220461)
- Testing
- Folic acid
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Calgary
Infant, Newborn, Infant, Low Birth Weight
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEC Surgery (NCT01223261)
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Extremely Premature, Voice
Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding
A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups.
- Conditions
- Infant, Extremely Premature, Voice, Pain, Bonding
- Trial name
- NCT04158206
- Testing
- Maternal voice
- Where
- Taiwan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- National Yang Ming Chiao Tung University
Premature; Infant, Light-for-dates
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in…
- Trial name
- NCT02915549
- Testing
- Progressive Feeding without MEF, Progressive Feeding with MEF
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
Kangaroo Care, Premature Infant
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less…
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Trial name
- Cangulat (NCT03990116)
- Testing
- Lateral, Prone
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Laura Collados Gomez
Infant,Premature
Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes.
- Trial name
- FiO2-C (NCT03168516)
- Testing
- closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
- Where
- 32 sites in China, Germany and 2 more
- Volunteers
- 1,065 people
- Sponsor
- University Hospital Tuebingen
Anemia of Prematurity
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.
- Trial name
- ETTNO (NCT01393496)
- Testing
- red blood cell transfusion
- Where
- 32 sites in Denmark, Germany
- Volunteers
- 1,013 people
- Sponsor
- University Hospital Tuebingen
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Prematurity; Extreme
Preterm Infants Born to Homeless Mothers.
In recent years, the number of homeless patients who are accommodated by the SAMU social has increased. These patients are in a situation of financial, but also often social and psychological precariousness.
- Trial name
- PREMA-NEUF (NCT05684419)
- Testing
- Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hôpital NOVO
Infant, Newborn, Infant, Low Birth Weight
Early Blood Pressure Management in Extremely Premature Infants
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- ELGAN BP (NCT00874393)
- Testing
- Dopamine, Hydrocortisone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- NICHD Neonatal Research Network