Clinical trials: Perinatal Disorder
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
- Trial name
- NCT00992836
- Testing
- Influenza A (H1N1) 2009 monovalent vaccine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 155 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Perinatal Hypoxia, Dopamine
Measuring Brain Activity of School Age Children
This observational study will investigate whether differences in birth events and oxygen levels during the newborn period affects the brain activity of children during the middle childhood years.
- Conditions
- Perinatal Hypoxia, Dopamine, Neurobehavioral Manifestations
- Trial name
- NCT03407729
- Testing
- Magnetic Resonance Imaging, Cognitive Performance Testing
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Case Western Reserve University
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Depression, Pregnancy
mHealth for Antenatal Mental Health
The aim of this study is to determine the feasibility of using mobile technology for: 1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical management and service guidance NICE guideline for…
- Trial name
- AMHS (NCT02516982)
- Testing
- Whooley Questions, Edinburgh Postnatal Depression Scale, Momentary questions
- Where
- 14 sites in United Kingdom
- Volunteers
- 946 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Hypophosphatasia (HPP)
A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP)
This study aims to characterize the natural history of patients with severe perinatal or infantile onset HPP.
- Trial name
- NCT01419028
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 48 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Depression, Postpartum
Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings.
- Trial name
- ROSE (NCT03267563)
- Testing
- EIAU, LICF, HICF
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Michigan State University
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
Smoking Cessation
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence.
- Trial name
- B-EPIC (NCT03796208)
- Testing
- Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC), Treatment As Usual
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Kristin Ashford
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Hepatitis B Chronic Infection, Pregnancy
Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV).
- Trial name
- iTAP (NCT01745822)
- Testing
- tenofovir disoproxil fumarate
- Where
- 17 sites in Thailand
- Volunteers
- 654 people
- Sponsor
- Institut de Recherche pour le Developpement
Perinatal Depression
Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal…
- Trial name
- SUMMIT (NCT04153864)
- Testing
- Brief Behavioral Activation Treatment
- Where
- 5 sites in United States, Canada
- Volunteers
- 1,230 people
- Sponsor
- Mount Sinai Hospital, Canada
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
Obesity, Overweight
Physical Exercise Influence Among Overweight and Obese Pregnant Women
Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life.
- Trial name
- NCT01136291
- Testing
- physical exercise
- Where
- 2 sites in Brazil
- Volunteers
- 82 people
- Sponsor
- University of Campinas, Brazil
Recurrent Miscarriage, Spontaneous Abortion
Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)
The present study is based on the hypothesis, that recurrent pregnancy loss (RPL) is associated with abnormal plasma mannose binding lectin (p-MBL) level.
- Conditions
- Recurrent Miscarriage, Spontaneous Abortion, Mannose-Binding Lectin Deficiency, Habitual Abortion
- Trial name
- NCT04017754
- Where
- Denmark
- Volunteers
- 452 people
- Sponsor
- Aalborg University Hospital
Perinatal Depression, Post Partum Depression
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period.
- Conditions
- Perinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
- Trial name
- NCT04051320
- Testing
- Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet, Micronized progesterone
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cerebral Palsy, Perinatal Stroke
Single-session tDCS in Cerebral Palsy
The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration…
- Conditions
- Cerebral Palsy, Perinatal Stroke, Periventricular Leukomalacia
- Trial name
- NCT03635775
- Testing
- Active tDCS
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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)