Clinical trials: In the Perinatal Period
Perinatal Asphyxia
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care
The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.
- Trial name
- OptiNeoCare (NCT06322732)
- Where
- France
- Volunteers
- 336 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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, Pregnancy
Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand
The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses…
- Trial name
- PHPT-5 (NCT00409591)
- Testing
- Maternal and infant nevirapine, Maternal lopinavir+ritonavir, zidovudine
- Where
- 43 sites in Thailand
- Volunteers
- 435 people
- Sponsor
- Institut de Recherche pour le Developpement
Hypoglycaemia
Point of Care Ketone Measurement in the Newborn
Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged.
- Trial name
- POCKET (NCT02341313)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Kathryn Beardsall
Perinatal Depression
Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression
The perinatal period (pregnancy and the first postnatal year) (O'Hara \& Wisner, 2014) involves important changes and considerable challenges for parents (Milgrom \& Gemmill, 2015).
- Trial name
- MaMHI (NCT07027761)
- Testing
- Online self-help, Maternal Mental Health Intervention (MaMHI), Usual Care
- Where
- Belgium
- Volunteers
- 210 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Infection
Determination of Gentamicin Dosing in Neonatal Patients
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
- Trial name
- NCT00198601
- Testing
- Gentamicin in Uniject Pre-filled syringe
- Where
- 3 sites in Bangladesh, India and 1 more
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Congenital Heart Disease, Fetal Heart Disorder
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on…
- Conditions
- Congenital Heart Disease, Fetal Heart Disorder, Neonatal Disease, Fetal Disease
- Trial name
- NCT07820163
- Volunteers
- 115 people
- Sponsor
- Assiut University
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia
Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy
There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe.
- Trial name
- STIM-CP (NCT02097693)
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital of Cologne
¨Maternal Morbidity¨, ¨Perinatal Mortality¨
A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health…
- Trial name
- NCT01653626
- Testing
- package of 3 interventions
- Where
- Guatemala
- Volunteers
- 1 people
- Sponsor
- Hospital San Juan de Dios Guatemala
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
Death; Neonatal, Morbidity;Newborn
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.
- Trial name
- NCT06087224
- Testing
- Teleneonatology
- Where
- 36 sites in United States, Canada
- Volunteers
- 947 people
- Sponsor
- Mayo Clinic
HIV-1
Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India
This study, conducted in Tamil Nadu, India, was initiated in response to the developing epidemic of HIV/AIDS in India. It is divided into two stages, as follows: Stage I All women registered in the pregnancy clinics at the…
- Trial name
- NCT00341796
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV/AIDS, Infant Morbidity
Impact of Point-of-Care EID for HIV-Exposed Infants
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers…
- Conditions
- HIV/AIDS, Infant Morbidity, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- POC-EID (NCT03824067)
- Testing
- Point of Care Early Infant Diagnosis, Standard of Care Early Infant Diagnosis
- Where
- 2 sites in Kenya, Zimbabwe
- Volunteers
- 9,539 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
HIV Infections
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children.
- Trial name
- NCT00001007
- Testing
- Zidovudine
- Where
- 6 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in…
- Trial name
- NCT00086359
- Testing
- Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine, Lopinavir/ritonavir
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 19 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Stillbirths, Sudden Infant Death
Magnetic Resonance Imaging Autopsy Study
The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and…
- Trial name
- MARIAS (NCT01417962)
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Thayyil, Sudhin
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy
The Effect of Teenage Maternity on Obstetrical and Perinatal Outcomes
The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women.
- Trial name
- NCT01115413
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- University of Luebeck
Neonatal Respiratory Distress
The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section
In this study, the investigators aim to investigate if artificial uterine contractions prior to elective caesarean section delivery may have an impact on the respiratory morbidity of term neonates.
- Trial name
- ARTCON (NCT03899597)
- Testing
- Oxytocin, Normal saline
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic