Clinical trials: Infant, Newborn
Infant, Premature, Patent Ductus Arteriosus
Management of the PDA Trial
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
- Conditions
- Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
- Trial name
- PDA (NCT03456336)
- Testing
- Active Treatment, Expectant Management
- Where
- 19 sites in United States
- Volunteers
- 482 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Syphilis, Congenital
Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics
Congenital syphilis in newborns requires intravenous antibiotic therapy, making reliable peripheral venous access essential. However, high rates of catheter failure and repeated punctures remain a significant clinical challenge.
- Conditions
- Infant, Newborn, Syphilis, Congenital, Catheterization, Peripheral, Ultrasonography
- Trial name
- ULTRA-ACCESS (NCT07568171)
- Testing
- Ultrasound-Guided Long Peripheral Intravenous Catheter, Short Peripheral Intravenous Catheter (Conventional Technique)
- Volunteers
- 104 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Intubation, Intubation Complications
A Stepped Wedge Cluster Randomised Trial Of Video Versus Direct Laryngoscopy For Intubation Of Newborn Infants
Many newborn babies have difficulty breathing. When babies need a lot of help, a doctor will intubate them - i.e. put a tube into their windpipe (trachea) - so that they can be given support with a breathing machine.
- Conditions
- Intubation, Intubation Complications, Infant, Newborn, Infant Respiratory Distress Syndrome
- Trial name
- NEU-VODE (NCT06757543)
- Testing
- Video laryngoscopy, Direct laryngoscopy with standard laryngoscope
- Where
- 17 sites in Croatia, Czechia and 8 more
- Volunteers
- 840 people
- Sponsor
- University College Dublin
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
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Aortic Coarctation, Retrospective Studies
Prevalence and Risk Factors for Hypertension and Recoarctation in Patients Operated for Aortic Coarctation
Multicenter Retrospective Study Over a 14-Year Period From 2010 to 2024
- Conditions
- Aortic Coarctation, Retrospective Studies, Cohort Studies, Hypertension
- Trial name
- PRECOHA (NCT07499609)
- Where
- France
- Volunteers
- 901 people
- Sponsor
- Institut Saint Pierre
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Newborn Infant, Newborn
Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation
The goal of this observational study is to determine whether, in a population of well-informed parents, choosing a general practitioner at the maternity hospital facilitates the completion of the newborn's first required medical…
- Trial name
- GENS2-VIE (NCT07329192)
- Testing
- Advance Selection of a General Practitioner
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Sud Francilien
Hemorrhage, Premature Infants
NIRS Monitoring in Premature Infants
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for…
- Conditions
- Hemorrhage, Premature Infants, Newborn, Hydrocephalus
- Trial name
- NCT02601339
- Testing
- ETV/CPC
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (>6 hours of life).
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome
- Trial name
- NCT07344714
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Endocrine Disruptors in Newborns and Infants
Impact of Parental Training in Endocrine Disruptors on the Excretion of Urinary Biomarkers in Newborns
The impact of the environment on health, responsible for a quarter of all deaths worldwide and costing more than €160 billion a year, is difficult to assess because of the complexity of exposure and interactions.
- Trial name
- FLOCON (NCT07349927)
- Testing
- Training, Questionnaires, Urinary dosage
- Where
- France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy
Investigating Cerebral Oxygenation in the Newborn
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Premature Infant Disease
- Trial name
- ICON (NCT05588960)
- Testing
- Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)
- Where
- United Kingdom
- Volunteers
- 99 people
- Sponsor
- University of Edinburgh
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn
Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia
This randomized controlled trial aims to examine the effects of Gentle Human Touch applied by fathers during the first hours of life on sucking performance, comfort level, and blood glucose values in newborns at risk for…
- Trial name
- NCT07302412
- Testing
- Gentle Human Touch, Standard Care Group
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Acibadem University
Neonatal Resuscitation, Neonatal Disease
Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed.
- Trial name
- CO2-Vent (NCT06258187)
- Testing
- Pedi-Cap
- Where
- United States
- Volunteers
- 632 people
- Sponsor
- University of Texas Southwestern Medical Center
Neonatal Resuscitation, Delivery Room Resuscitation
Supraglottic Airway for Resuscitation Trial
This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation, with a focus on…
- Conditions
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive Pressure Ventilation, Infant, Newborn
- Trial name
- SUGAR (NCT07150923)
- Testing
- Enhanced Standard of Care ("Enhanced"), Enhanced Standard of Care ("Enhanced-Plus")
- Where
- 30 sites in United States
- Volunteers
- 36,503 people
- Sponsor
- Children's Hospital of Philadelphia
Biliary Atresia, Kasai
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG).
- Conditions
- Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
- Trial name
- NCT07250854
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Infant, Newborn, Diseases, Colic, Infantile
Acupuncture in Infantile Colic - A Randomised Trial.
About 10 per cent of all new born babies in Sweden have infant colic. This may affect the the whole family and the early connection between the baby and the parents. Although, there are no effective and safe treatment.
- Conditions
- Infant, Newborn, Diseases, Colic, Infantile, Acupuncture
- Trial name
- NCT05894798
- Testing
- Acupuncture
- Sponsor
- Region Skane