Clinical trials: Preterm Neonates
Endotracheal Tube Tip Position, Bronchopulmonary Dysplasia
Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants
Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the…
- Conditions
- Endotracheal Tube Tip Position, Bronchopulmonary Dysplasia, Pneumothorax, Death
- Trial name
- ELEGANT (NCT04393337)
- Testing
- Gestational Age Chart Method, Nasal-Tragus Length Method
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 454 people
- Sponsor
- Princess Nourah Bint Abdulrahman University
Extreme Prematurity, Neurodevelopmental Abnormality
Osteopathic Manipulative Medicine to Reduce Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
- Trial name
- NCT04652063
- Testing
- Osteopathic Manipulative Medicine
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Patent Ductus Arteriosus, Infant, Premature
Ibuprofen vs Expectant Management for hsPDA in Preterm Infants: Retrospective Cohort
This retrospective cohort study compares ibuprofen treatment versus expectant management for hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants.
- Trial name
- IMPACT-PDA (NCT07533721)
- Testing
- Ibuprofen
- Where
- China
- Volunteers
- 541 people
- Sponsor
- Shengjing Hospital
Bronchopulmonary Dysplasia (BPD), Chronic Lung Disease of Newborn
Long-Term Burden of BPD and Health-Related Quality of Life (BronQ Family)
The objective of this study is to examine the long-term impact of having a child with Bronchopulmonary Dysplasia (BPD) on the parents and caregivers from the time of diagnosis through adulthood.
- Conditions
- Bronchopulmonary Dysplasia (BPD), Chronic Lung Disease of Newborn, HRQOL (Health Related Quality Of Life)
- Trial name
- BronQ Family (NCT07134387)
- Testing
- N/A, no intervention, participation in survey
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Global Foundation for the Care of Newborn Infants
Bronchopulmonary Dysplasia, Hyaline Membrane Disease
Inhaled Beclomethasone to Prevent Chronic Lung Disease
To test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Hyaline Membrane Disease, Lung Diseases
- Trial name
- NCT00000576
- Testing
- beclomethasone
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Prematurity
Ultrasound Monitoring of Muscle Thickness in Premature Patients
The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with…
- Trial name
- NeoMassage (NCT06273202)
- Testing
- Infant Massage
- Where
- Italy
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Skin Disorder
Characterization of Pre-Term Neonatal Skin
The skin of pre-term neonates is not fully developed and often leads to trans-epidermal water loss, trouble regulating temperature, and increased risk of skin wounds.
- Trial name
- NCT05127044
- Testing
- Diffuse Reflectance Spectroscopy, BiliChek
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
Premature Birth
Developmental Care Program in Neonatal Intensive Care Unit
This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
- Trial name
- CIN (NCT05573945)
- Testing
- Family Education and Active Listening, Family Education
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- University of Pisa
Infant, Newborn, Diseases
Electrogastrography (EGC) in Premature Infants With Feeding Intolerance
Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
- Trial name
- NCT00008736
- Testing
- metoclopramide
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)
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
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
Patent Ductus Arteriosus After Premature Birth
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, < 27+0 weeks).
- Trial name
- NCT05340582
- Testing
- Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection
- Where
- 9 sites in Australia, Canada and 2 more
- Volunteers
- 310 people
- Sponsor
- Mount Sinai Hospital, Canada
Bacterial Vaginosis, Fetal Membranes, Premature Rupture
Perinatal Infections in Pakistan
There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues…
- Conditions
- Bacterial Vaginosis, Fetal Membranes, Premature Rupture, Chorioamnionitis, Pregnancy
- Trial name
- NCT00070746
- Where
- Pakistan
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Preterm, Low Birthweight
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh.
- Conditions
- Preterm, Low Birthweight, Hypothermia Neonatal
- Trial name
- NCT06277843
- Testing
- Thermal Jacket
- Where
- Bangladesh
- Volunteers
- 10 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
NHFOV as Primary Support in Very Preterm Infants With RDS
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China.
- Trial name
- NCT05141435
- Testing
- infants receive primary non-invasive respiratory support by mean of nCPAP, infants receive primary non-invasive respiratory support by mean of NHFOV
- Where
- 3 sites in China
- Volunteers
- 360 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Infant Respiratory Distress Syndrome, Ventilator Lung; Newborn
Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants
Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or…
- Trial name
- CLAC-4 (NCT03163108)
- Testing
- Closed-loop automatic oxygen control (CLAC) fast in addition to RMC, Closed-loop automatic oxygen control (CLAC) slow in addition to RMC
- Where
- 2 sites in Germany
- Volunteers
- 19 people
- Sponsor
- University Hospital Tuebingen
Cerebral Blood Flow
Cerebral Blood Flow in Term and Preterm Neonates Using Doppler Ultrasonography
This study aims to evaluate cerebral blood flow in stable term and preterm newborns using Doppler ultrasonography. By measuring and comparing PSV, EDV, RI, and PI in the main brain arteries, the study seeks to identify normal…
- Trial name
- NCT07427342
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Assiut University
Bronchopulmonary Dysplasia, Child Development
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- MOBYDIck (NCT02371460)
- Testing
- DHA-rich algal oil
- Where
- 16 sites in Canada
- Volunteers
- 461 people
- Sponsor
- CHU de Quebec-Universite Laval
Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal
Continuous Monitoring of Lung Ventilation
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea, Respiration Disorders
- Trial name
- NCT00810186
- Where
- 3 sites in Israel
- Volunteers
- 77 people
- Sponsor
- Pneumedicare Ltd.
Bronchiolitis; Respiratory Syncytial Virus
RSV Seasonality in Martinique in Children Aged 2 Years or Less
The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in…
- Trial name
- VRS-12 (NCT04415229)
- Where
- Martinique
- Volunteers
- 1,237 people
- Sponsor
- University Hospital Center of Martinique
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