Clinical trials: Neonatal
Neonatal Death, Perinatal Death
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and…
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Trial name
- NCT04598165
- Testing
- Interactive two-way SMS dialogue
- Where
- 6 sites in Kenya
- Volunteers
- 5,020 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Adverse Reaction to Drug, Neonatal Disorder
Exploratory Propofol Dose Finding Study In Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure…
- Trial name
- NEOPROP (NCT01621373)
- Testing
- propofol administration
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Maternal Death, Maternal Morbidity
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in…
- Conditions
- Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death
- Trial name
- BetterBirth (NCT02148952)
- Testing
- WHO Safe Childbirth Checklist Program
- Where
- India
- Volunteers
- 157,689 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Perinatal Arterial Ischemic Stroke, Neonatal Stroke
Perinatal Arterial Stroke Treated With Stromal Cells Intranasally
This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, administered by the nasal route, in neonates who suffered from PAIS.
- Trial name
- PASSIoN (NCT03356821)
- Testing
- Mesenchymal Stem Cells
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Electroencephalographic Neonatal Seizures
A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures
The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the…
- Trial name
- NCT03325439
- Testing
- Brivaracetam (BRV) intravenous (iv), Brivaracetam (BRV) oral
- Where
- 12 sites in Belgium, Czechia and 5 more
- Volunteers
- 9 people
- Sponsor
- UCB Biopharma SRL
Maternal Opioid Use Disorder, Opioid Exposed Infant
Maternal Buprenorphine-naloxone Treatment and the Infant
The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant.
- Trial name
- NCT03291847
- Testing
- fetal monitoring, Buprenorphine Naloxone
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Johns Hopkins University
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke 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
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy Mild
Mild Encephalopathy in the Newborn Treated With Darbepoetin
This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at…
- Trial name
- MEND (NCT03071861)
- Testing
- Darbepoetin Alfa, Normal Saline
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of New Mexico
Epilepsy, Benign Neonatal
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure.
- Trial name
- NCT04320940
- Testing
- Phenobarbital Sodium Injection
- Where
- 8 sites in United States, Jordan
- Volunteers
- 4 people
- Sponsor
- NEMA Research, Inc.
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Premature Birth, Neonatal Hypoxic Conditions
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
- Trial name
- Vanilla (NCT02630147)
- Testing
- Vanilla scent
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Université de Sherbrooke
Neonatal Abstinence Syndrome
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with…
- Trial name
- NCT03134703
- Testing
- Methadone, Morphine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Johns Hopkins All Children's Hospital
Neonatal Abstinence Syndrome
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero.
- Trial name
- NCT02851303
- Testing
- Morphine, Methadone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of New Mexico
Neonatal Abstinence Syndrome
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared…
- Trial name
- NCT03762317
- Testing
- Clonidine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hennepin County Medical Center, Minneapolis
Neonatal Encephalopathy, Birth Asphyxia
High-dose Erythropoietin for Asphyxia and Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth.
- Trial name
- HEAL (NCT02811263)
- Testing
- Erythropoietin
- Where
- 23 sites in United States
- Volunteers
- 500 people
- Sponsor
- University of California, San Francisco
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health