Clinical trials: Infant Outcomes
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy, Infants
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in…
- Conditions
- Pregnancy, Infants, Disparities
- Trial name
- PᵌOPPY (NCT05940688)
- Testing
- Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Apnea of Prematurity, Intraventricular Hemorrhage
MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems.
- Conditions
- Apnea of Prematurity, Intraventricular Hemorrhage, Brain Injury
- Trial name
- NCT00809055
- Testing
- Caffeine citrate
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine
Bronchopulmonary Dysplasia
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants.
- Trial name
- NCT01748045
- Testing
- inhaled nitric oxide
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Tufts Medical Center
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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
Neurodevelopmental Abnormality
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
- Trial name
- MINVIFU (NCT03621943)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,207 people
- Sponsor
- Sharp HealthCare
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Infant Development, Hemiplegia
CIMT and taVNS for Hemiplegia in Infants
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body.
- Conditions
- Infant Development, Hemiplegia, Constraint Induced Movement Therapy
- Trial name
- NCT05101707
- Testing
- transcutaneous auricular vagus nerve stimulation, Constraint induced movement therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Medical University of South Carolina
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Infant Development, Infant,Premature
Movement-based Infant Intervention
The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay.
- Conditions
- Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age
- Trial name
- NCT03082313
- Testing
- Movement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Southern California
Intraventricular Hemorrhage of Prematurity
Tortle Midliner and Intraventricular Hemorrhage
The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs.
- Trial name
- IVH (NCT03543046)
- Testing
- Tortle Midliner
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Orlando Health, Inc.
Premature Birth
Feeding and Transition to Home for Preterms at Social Risk
Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures'…
- Trial name
- H-HOPE (NCT02041923)
- Testing
- H-HOPE, Attention Control
- Where
- 2 sites in United States
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University of Illinois at Chicago
Obstetric Labour, Premature
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide…
- Trial name
- ARIOS (NCT02292784)
- Testing
- Retosiban, Atosiban
- Where
- 26 sites in United States, Belgium and 9 more
- Volunteers
- 98 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Viruses
A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity…
- Trial name
- NCT03333317
- Testing
- Lumicitabine
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 7 people
- Sponsor
- Janssen Research & Development, LLC
Neonatal Abstinence Syndrome
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating…
- Trial name
- NCT02801331
- Testing
- Stochastic Vibrotactile Stimulation (SVS)
- Where
- United States
- Volunteers
- 208 people
- Sponsor
- Elisabeth B Salisbury
Obesity, Infant, Language Development
Music and Child Health and Development
The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old…
- Conditions
- Obesity, Infant, Language Development, Parent-Child Relations
- Trial name
- NCT05868811
- Testing
- Music Together, Play Group
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island