Clinical trials: Infants, Extremely Premature
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
Extremely Low Birth Weight
The Effect of Schumann Resonance on Preterm Newborns
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are…
- Trial name
- NCT05146752
- Testing
- extremely low frequency electromagnetic fields, routine care
- Where
- Taiwan
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Chung Shan Medical University
Neonatal Respiratory Failure
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange.
- Trial name
- Flow&Grow (NCT06123143)
- Testing
- Standardized/structured CPAP weaning protocol
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- University of California, San Diego
Extreme Immaturity
Sodium Supplementation and Growth in Very Low Birth Weight Infants
Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total…
- Trial name
- SSALT (NCT01795638)
- Testing
- Sodium chloride
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Premature Birth, Infant, Extremely Low Birth Weight
Additional Protein Fortification in Extremely Low Birth Weight Infants
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
- Conditions
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- Trial name
- PROTSUP (NCT02515266)
- Testing
- nutrition: protein intake
- Volunteers
- 152 people
- Sponsor
- Hôpital de la Croix-Rousse
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
Infant, Newborn, Infant, Low Birth Weight
Growth Observational Study
This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Growth (NCT01203475)
- Where
- 13 sites in United States
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Newborn, Extreme Prematurity
Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of…
- Conditions
- Newborn, Extreme Prematurity, Pretrm Infants
- Trial name
- PREMEX (NCT05248477)
- Testing
- Premex Protocol
- Where
- France
- Volunteers
- 2,377 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy
Significance of Ultrasound Combined with Near-Infrared Spectroscopy in Monitoring Transfusion-Associated Intestinal Injury in Extremely Preterm Infants: a Study Protocol for a Prospective, Observational Study
Background: Most preterm infants with a gestational age <32 weeks in the neonatal intensive care unit (NICU) undergo blood transfusion therapy during their hospital stay to enhance their oxygen-carrying capacity and improve the…
- Trial name
- NCT06857812
- Testing
- there is no intervention
- Volunteers
- 100 people
- Sponsor
- Peking University Third Hospital
Prematurity Complications, Neurodevelopment Outcome
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births…
- Conditions
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- Trial name
- OutbornTRANSF (NCT07580859)
- Testing
- Usual Care
- Where
- France
- Volunteers
- 627 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Bronchopulmonary Dysplasia, Neurodevelopmental Impairment
Lipid Infusions to Optimize Nutrition Trial
The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based…
- Trial name
- LION (NCT06915441)
- Testing
- SOLE, MOLE
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- The University of Texas Health Science Center, Houston
Prematurity; Extreme, Feeding Difficulties
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination.
- Trial name
- STIMPREM (NCT07632066)
- Testing
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Hôpital de la Croix-Rousse
Magnesium Deficiency, Preterm Birth
A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy
The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive…
- Conditions
- Magnesium Deficiency, Preterm Birth, Extreme Immaturity
- Trial name
- NCT02032186
- Testing
- Magnesium citrate
- Where
- Brazil
- Volunteers
- 3,000 people
- Sponsor
- Professor Fernando Figueira Integral Medicine Institute
Prematurity, Extreme Prematurity
Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes…
- Trial name
- NCT04256889
- Testing
- nfant(R) feeding system
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Woman's
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Infection, Candida
Early Diagnosis of Candidiasis in Premature Infants
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn
- Trial name
- Candida (NCT00109525)
- Where
- 20 sites in United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome in Premature Infant
Physiological Changes With High-Flow Nasal Cannula
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
- Trial name
- NCT03700606
- Testing
- High flow nasal cannula, Nasal CPAP
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Sharp HealthCare