Clinical trials: Newborn Infant
Newborn Infant, Newborn Health
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins.
- Conditions
- Newborn Infant, Newborn Health, Delayed Cord Clamping
- Trial name
- Cord Clamping (NCT07719751)
- Testing
- Prone position, Left side lying position
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mersin University
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes.
- Conditions
- Tobacco Smoke Pollution, Maternal Exposure During Pregnancy, Infant, Newborn, Carbon Monoxide Poisoning
- Trial name
- NCT07201181
- Testing
- Maternal Urinary Cotinine Assessment
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Haseki Training and Research Hospital
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxemia, Neonatal Disease
Evaluation of a Multi-country Medical Oxygen Program
REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for…
- Conditions
- Hypoxemia, Neonatal Disease, Pneumonia, Sepsis
- Trial name
- REAL-MOXY (NCT06087315)
- Testing
- Multi-faceted oxygen systems strengthening interventions (different for each country)
- Where
- 3 sites in Cambodia, Nigeria and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Murdoch Childrens Research Institute
Retinopathy of Prematurity, Newborns
A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea.
- Conditions
- Retinopathy of Prematurity, Newborns, Infants
- Trial name
- NCT05705258
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Japan
- Volunteers
- 75 people
- Sponsor
- Bayer
Infant, Newborn, Infant, Low Birth Weight
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- FU (NCT00009633)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 68,000 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Intubation, Intratracheal
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen…
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Trial name
- NEORIN (NCT07650552)
- Testing
- Rocuronium Bromide 10 MG/ML, Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- UEA - Universidade Do Estado Do Amazonas
Neonatal Pain, Retinopathy of Prematurity (ROP)
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm…
- Conditions
- Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature
- Trial name
- FIREFLY (NCT07112430)
- Testing
- Fentanyl Citrate (Intranasal)
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- Marsha Campbell-Yeo
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs.
- Trial name
- FLOW-VENT (NCT07101419)
- Testing
- Long PRT, Short PRT
- Where
- 3 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Murdoch Childrens Research Institute
İnfant Comfort, Infant
EFFECTS OF TWO PAİN MANAGEMENT EDUCATİON METHODS DURİNG HEEL PRİCK PROCEDURES ON MATERNAL ANXİETY AND NEONATAL PAİN
The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain…
- Conditions
- İnfant Comfort, Infant, Infant Care, Newborn Pain
- Trial name
- NCT07660159
- Testing
- verbal and brochure-based education, verbal and AI-supported video training
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Kocaeli University
Cerebral Autoregulation, Near-infrared Spectroscopy
Determination of Blood Pressure Limit of Cerebral Autoregulation During Non-cardiac Surgery in Preterm Infants, Neonates and Term Infants: a Prospective Observational Study Using Near-infrared Spectroscopy Monitoring
This prospective observational study aims to determine the blood pressure range in which cerebral autoregulation is maintained in preterm neonates, preterm infants, term neonates, and term infants undergoing non-cardiac surgery…
- Conditions
- Cerebral Autoregulation, Near-infrared Spectroscopy, Infant, Newborn, General Anesthesia
- Trial name
- NCT07660302
- Where
- South Korea
- Volunteers
- 160 people
- Sponsor
- Seoul National University Hospital
Newborn, Infant, Body Temperature
Management of Healthy Newborn's Body Temperature at Birth
At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb)…
- Conditions
- Newborn, Infant, Body Temperature, Delivery Room
- Trial name
- NCT06275932
- Testing
- Interventional group, Standard of care group
- Where
- Italy
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Hyper Bilirubinemia, Premature Infant
Cycled Phototherapy
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA).
- Trial name
- NCT03927833
- Testing
- Phototherapy lights
- Where
- 19 sites in United States
- Volunteers
- 1,700 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Immunity
The Bloom Infant Probiotic (BIP) Study
The goal of this clinical trial is to investigate whether administering a probiotic (Infloran®) to infants who received antibiotics in the first 28 days of life can restore or enhance their immune response to routine vaccines.
- Conditions
- Infant, Newborn, Immunity, Immunisation, Antibiotic Treatment
- Trial name
- BIP (NCT07189390)
- Testing
- Probiotic
- Where
- 2 sites in Australia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- South Australian Health and Medical Research Institute
Body Composition, Feeding; Difficult, Newborn
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment.
- Conditions
- Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
- Trial name
- NCT04599010
- Testing
- Dietary intervention
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Breastfeeding, Newborn Infant
Effect of Topical Oxygen and LED Light Therapy on Nipple Crack
The World Health Organization and UNICEF define the protection and support of breastfeeding as one of the key determinants of maternal and newborn health.
- Conditions
- Breastfeeding, Newborn Infant, Midwifery, Breast
- Trial name
- NCT07370051
- Testing
- Topical oxygen therapy, LED light therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people
- Sponsor
- Istanbul University - Cerrahpasa
Newborn, Infant, Disease, Neurodevelopmental Disorders
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal…
- Trial name
- miniNO-COVID (NCT04952870)
- Testing
- Inhaled NO, routine care
- Where
- 2 sites in France, Greece
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille