Clinical trials: Infant Outcomes
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
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
Cognitive Change
Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula
The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA.
- Trial name
- NCT06146387
- Testing
- Investigational Formula, Control Formula, Breastfeeding
- Where
- 3 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Jaundice, Neonatal Hyperbilirubinemia
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.
- Trial name
- NCT02033096
- Testing
- Stannsoporfin, Phototherapy (as needed)
- Volunteers
- 42 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Chronic Idiopathic Constipation (CIC)
A Study of Prucalopride in Breastfeeding Women With Constipation
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk.
- Trial name
- NCT04838522
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Takeda
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
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
Mucopolysaccharidosis II
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity…
- Trial name
- NCT04007536
- Testing
- No Intervention
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 18 people
- Sponsor
- Denali Therapeutics Inc.
User Experience of Mobile Application
User Experience of a Mobile Application
To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants
- Trial name
- SMart (NCT04231188)
- Where
- Singapore
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Influenza, Human, Arthralgia
An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality.
- Trial name
- NCT04494412
- Testing
- Zanamivir
- Where
- 6 sites in Italy, Poland and 1 more
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis (AD), Asthma
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison…
- Trial name
- NCT04173442
- Testing
- dupilumab
- Where
- United States
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical…
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases
- Trial name
- STREETON (NCT07122661)
- Testing
- ABRYSVO
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Pfizer
Healthy
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.
- Trial name
- NCT00983606
- Where
- 222 sites in United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Retinopathy of Prematurity
Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)
Primary objectives of the study are: To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
- Trial name
- NCT04515524
- Testing
- Non-Interventional
- Where
- 30 sites in United States, Bulgaria and 8 more
- Volunteers
- 100 people
- Sponsor
- Regeneron Pharmaceuticals
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
- Conditions
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Trial name
- NCT05908682
- Testing
- Non-interventional study
- Where
- India
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Formula Feeding of Healthy Full Term Infants
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune…
- Trial name
- NCT01197365
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Heinz Italia SpA
Migraine
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.
- Trial name
- NCT05198245
- Testing
- Rimegepant, Various, No intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Cow Milk Protein Allergy, FPIES
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based…
- Trial name
- PANDA (NCT07592182)
- Testing
- Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3
- Volunteers
- 55 people
- Sponsor
- Lactalis
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
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.