Clinical trials: Death; Neonatal
Neonatal Death, Perinatal Death
Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya
Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in…
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Trial name
- AI-NEO (NCT05369806)
- Testing
- Interactive two-way SMS dialogue
- Where
- 2 sites in Kenya
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Washington
Mucopolysaccharidoses
Carotid Structure and Function in MPS Syndromes: A Multicenter Study of the Lysosomal Disease Network
Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies, and they have been linked to heart health complications.
- Trial name
- NCT01586871
- Where
- 2 sites in United States
- Volunteers
- 1,147 people
- Sponsor
- University of Minnesota
Primary Immunodeficiency, PID
Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched CD3+/CD19+ depleted bone marrow transplant (BMT) is safe and effective for individuals…
- Trial name
- BOLT-BMT (NCT03330795)
- Testing
- CD3/CD19 neg allogeneic BMT
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hunter Syndrome
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do…
- Trial name
- NCT00882921
- Testing
- Idursulfase
- Where
- 6 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- Shire
Perinatal Death, Neonatal Death
Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
The purpose of this study is to conduct Verbal Autopsies of deaths ( stillbirths and neonatal deaths together) identified in the BetterBirth trial to identify their potential causes, timing, and social determinants.
- Conditions
- Perinatal Death, Neonatal Death, Stillbirth
- Trial name
- NCT03213509
- Testing
- Interview (Social and Verbal Autopsy)
- Where
- India
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Mucopolysaccharidosis II
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)
The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.
- Trial name
- NCT00069641
- Testing
- Iduronate-2-sulfatase enzyme replacement therapy
- Where
- 9 sites in United States, Brazil and 2 more
- Volunteers
- 96 people
- Sponsor
- Shire
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Infant, Small for Gestational Age, Infant, Low Birth Weight
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help…
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep
- Trial name
- KBTH-HBWS (NCT03062228)
- Where
- Ghana
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Neonatal Death, Prematurity
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
BACKGROUND An essential part of neonatal care is providing nutrition to ensure that babies grow and develop. Providing this can be difficult in premature babies because their intestines are underdeveloped.
- Trial name
- NCT03767634
- Testing
- Parenteral nutrition
- Where
- United Kingdom
- Volunteers
- 97,507 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Cardiomyopathy, Dilated, Arrhythmia
Mental Stress Reduction in Defibrillator Patients
The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable…
- Conditions
- Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
- Trial name
- NCT00624520
- Testing
- Cognitive Behavioral Stress Management (CBSM), Patient Education
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- US Department of Veterans Affairs
Stillbirth, Neonatal Death
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital…
- Trial name
- NCT02273037
- Testing
- Fetal heart rate Doppler, Partograph
- Where
- 2 sites in Canada, Uganda
- Volunteers
- 1,987 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Maternal Death, Neonatal Death
Incentives for Postnatal Care Demand
The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT).
- Trial name
- NCT02936869
- Testing
- Performance-based monetary incentives
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Biliary Tract Cancer, Cholangiocarcinoma
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current…
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT04066491
- Testing
- M7824, Gemcitabine, Cisplatin
- Where
- 99 sites in United States, Argentina and 13 more
- Volunteers
- 309 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
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
Vitamin A Deficiency, Maternal Mortality
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three…
- Conditions
- Vitamin A Deficiency, Maternal Mortality, Infant Mortality
- Trial name
- NCT00198822
- Testing
- Vitamin A or Beta-Carotene Supplements
- Where
- 3 sites in United States, Bangladesh
- Volunteers
- 59,666 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Prolonged QT Interval in EKG and Sudden Death
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the…
- Trial name
- NCT01929083
- Testing
- Progesterone, Ibutilide
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Indiana University
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Diaphragmatic Hernia, Lung Disease
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.
- Trial name
- NCT00966823
- Testing
- Fetal tracheal obstruction with detachable balloon (device)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Rhode Island Hospital