Clinical trials: Infant, Extremely Premature
Patent Ductus Arteriosus After Premature Birth
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, < 27+0 weeks).
- Trial name
- NCT05340582
- Testing
- Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection
- Where
- 9 sites in Australia, Canada and 2 more
- Volunteers
- 310 people
- Sponsor
- Mount Sinai Hospital, Canada
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
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
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
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates
This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD.
- Trial name
- NCT05071638
- Testing
- autologous cord blood mononuclear cells
- Where
- 2 sites in China
- Volunteers
- 76 people
- Sponsor
- Guangdong Women and Children Hospital
Premature Infants
Urine Concentration of S100B in Extremely Premature Infants
S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study.
- Trial name
- NCT00747591
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Utah
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Ventilator Pressure and Optimization of Compliance and Hemodynamics
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and…
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn
- Trial name
- VPOCH (NCT06512935)
- Testing
- Increase in the PEEP followed by decrease in the PEEP, Decrease in the PEEP followed by increase in the PEEP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Alabama at Birmingham
Infant, Newborn, Infant, Low Birth Weight
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- STOP-ROP (NCT01203436)
- Testing
- Supplemental Oxygen Management, Conventional Oxygen Management
- Where
- 9 sites in United States
- Volunteers
- 649 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Extreme Prematurity
Protein for Premies
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care.
- Trial name
- NCT01773902
- Testing
- High Dose Protein (Individualized), High Dose Protein (Standardized), Standard Protein Supplementation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Tuebingen
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
- Trial name
- NCT04284280
- Testing
- Routine vs Selective use of Human Milk Donor Fortifier
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Crouse Hospital
Prematurity, Extreme Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage
- Trial name
- Premalocom2 (NCT06027645)
- Testing
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Marianne Barbu-Roth
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
Infant, Low Birth Weight, Anemia
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
- Trial name
- EPO (NCT00593801)
- Testing
- epoetin beta
- Where
- Germany
- Volunteers
- 219 people
- Sponsor
- Charite University, Berlin, Germany
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
Influenza, Infant, Premature
Influenza Vaccine in Premature Infants
Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates…
- Trial name
- NCT00455169
- Testing
- Trivalent Inactivated Influenza Vaccine
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- University of Rochester
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- Phototherapy (NCT00114543)
- Testing
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g, Conservative Phototherapy 501-750g
- Where
- 17 sites in United States
- Volunteers
- 1,974 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
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston