Clinical trials: Infant, Extremely Premature
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
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have…
- Trial name
- EPIREMED (NCT02757794)
- Testing
- computerized cognitive remediation program, standard remediation
- Where
- 18 sites in France
- Volunteers
- 166 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Infant, Newborn, Infant, Low Birth Weight
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PPHN (NCT01203423)
- Where
- 13 sites in United States
- Volunteers
- 385 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth
Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants.
- Trial name
- NCT01913288
- Testing
- Biological Maternal Sounds
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Brigham and Women's Hospital
Preterm, Extreme Prematurity
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.
- Conditions
- Preterm, Extreme Prematurity, Early Intervention, Developmental Delay
- Trial name
- NCT05334550
- Testing
- Home Based Early Intervention by Parent
- Volunteers
- 110 people
- Sponsor
- Samsung Medical Center
Growth in Premature Infants
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater…
- Trial name
- NCT01991613
- Testing
- liquid protein supplement
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Prematurity; Extreme, Inflammation
Anakinra for Preterm Infants Pilot
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
- Trial name
- NCT05280340
- Testing
- Anakinra
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Monash Medical Centre
Hypertriglyceridemia, Hyperglycemia
Intravenous Fat Emulsions and Premature Infants
The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who are born at less than 750 grams who are started at a higher infusion rate of intravenous lipid emulsions (2 gm/kg/day).
- Trial name
- NCT01096446
- Testing
- Intravenous Fat Emulsions
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- OSF Healthcare System
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
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
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Parent-Child Relations, Parents
Therapist Education and Massage for Parent Infant-Outcomes
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant…
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Trial name
- TEMPO (NCT04121897)
- Testing
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Extreme Prematurity, Birth, Preterm
Evaluating Decisional Regret Among Mothers
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery.
- Conditions
- Extreme Prematurity, Birth, Preterm, Pregnancy Preterm
- Trial name
- NCT04074525
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- Christiana Care Health Services
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Bronchopulmonary Dysplasia
Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first…
- Trial name
- DEPRECOD (NCT05055193)
- Testing
- Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon
Prematurity; Extreme, Low Birthweight, Extremely (999 Grams or Less)
Extremely Low Gestatonal Age Infants' Paracetamol Study
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
- Trial name
- Paras (NCT03641209)
- Testing
- Paracetamol 10mg/mL infusion solution
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- Outi Aikio
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Hyperbilirubinemia, Premature Newborns
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled…
- Conditions
- Hyperbilirubinemia, Premature Newborns, Extremely Low Birth Weight
- Trial name
- NCT01944696
- Testing
- phototherapy
- Where
- 6 sites in United States
- Volunteers
- 210 people
- Sponsor
- The University of Texas Health Science Center, Houston
Left Ventricular Hypertrophy
Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
Hypothesis/Study question In infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content? Study objectives To measure effects…
- Trial name
- SPEC (NCT04644094)
- Testing
- Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bronchopulmonary Dysplasia, Apnea of Prematurity
Early Versus Late Caffeine for ELBW Newborns
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which…
- Trial name
- NCT02524249
- Testing
- Caffeine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Wayne State University