Clinical trials: Premature Neonates
Preterm Membrane Rupture, Neonatal Sepsis
Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity.
- Trial name
- NCT04528251
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Pregnancy, Pregnancy Complications
AI-POCUS for Maternal and Neonatal Health in Ethiopia
Maternal and neonatal health remains one of the most pressing global health challenges, particularly in low- and middle-income countries (LMICs).
- Conditions
- Pregnancy, Pregnancy Complications, Preterm Birth, Fetal Growth Restriction
- Trial name
- AIM-ETH (NCT07171086)
- Testing
- AI-POCUS (BabyChecker, Delft Imaging), AI-POCUS (Edan, China)
- Where
- Ethiopia
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Tsinghua University
Preterm Infant, Body Temperature
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment.
- Trial name
- ThermoKPreterm (NCT03919188)
- Testing
- air temperature control (ATC), skin servocontrol (SSC)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Premature Rupture of Membranes (PROM)
Planned Early Induction of Labor vs Expectant Management for PROM
The goal of this randomized controlled trial is to compare planned early induction of labor with expectant management in women with term premature rupture of membranes (PROM) at 37-42 weeks of gestation.
- Trial name
- NCT07802041
- Testing
- Induction of labor with PGE2, Expectant management
- Where
- Pakistan
- Volunteers
- 734 people
- Sponsor
- Pakistan Institute of Medical Sciences
Premature
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother.
- Trial name
- DHARMA (NCT01062373)
- Testing
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Where
- France
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Neonatal Respiratory Distress Syndrome
Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
Respiratory distress is one of the first hospital grounds during the neonatal period. The clinical presentation and severity vary by gestational age and cause.
- Trial name
- DROPE (NCT02824497)
- Testing
- No intervention. It's a description study
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Behavior, Nesting, Behavior, Child
Hammock Position and Nesting in the Neonatal Intensive Care Unit
This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.
- Trial name
- NCT06209060
- Testing
- Hammock Position, Nesting
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Maltepe University
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and…
- Trial name
- NCT01941524
- Testing
- Poractant alfa instillation, Beractant instillation
- Where
- Poland
- Volunteers
- 22 people
- Sponsor
- Poznan University of Medical Sciences
Premature Lungs, Respiratory Distress Syndrome
Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants
This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life…
- Conditions
- Premature Lungs, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- Trial name
- CaLI (NCT04209946)
- Testing
- Less Invasive Surfactant Administration LISA, Continuous Positive Airway Pressure CPAP
- Where
- 3 sites in United States
- Volunteers
- 180 people
- Sponsor
- Sharp HealthCare
Infants Admitted to Neonatal Units, Preterm
Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants
Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy…
- Conditions
- Infants Admitted to Neonatal Units, Preterm, Physiotherapy and Rehabilitation, Family Centered
- Trial name
- NCT07201805
- Testing
- Early Physiotherapy Program, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Bronchopulmonary Dysplasia of Newborn
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary…
- Trial name
- SILDI-SAFE (NCT04447989)
- Testing
- Sildenafil
- Where
- 25 sites in United States
- Volunteers
- 125 people
- Sponsor
- Christoph Hornik
Bronchopulmonary Dysplasia
Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below.
- Trial name
- NCT07561125
- Testing
- intravenous immunoglobulin
- Where
- China
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- International Peace Maternity and Child Health Hospital
Hypothyroxinemia
L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG).
- Trial name
- NCT01306227
- Testing
- L-Thyroxine, water
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Neonatal Sepsis
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.
- Trial name
- NCT04474327
- Testing
- Montelukast Sodium
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Mansoura University Children Hospital
Hypotension, Low Blood Pressure
Management of Hypotension In the Preterm Infant
The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in extremely low gestational age newborns (Standard with dopamine versus a restricted with placebo…
- Conditions
- Hypotension, Low Blood Pressure, Intraventricular Hemorrhage of Prematurity
- Trial name
- HIP (NCT01482559)
- Testing
- Dopamine hydrochloride, Dextrose 5%
- Where
- 10 sites in Belgium, Canada and 3 more
- Volunteers
- 58 people
- Sponsor
- University College Cork
Breastfeeding
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
Retinopathy of Prematurity
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- BabySTEPS2 (NCT04995341)
- Testing
- Investigational ultracompact OCT and OCTA system, retinal photographs
- Where
- 2 sites in United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Duke University
Neonatal Disease, Intubation; Difficult or Failed
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
- Trial name
- NCT06263790
- Testing
- Intubating laryngeal mask, Direct laryngoscopy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Prematurity
Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01483079)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Baylor College of Medicine
Pain
Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns
Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns.
- Trial name
- NCT06438731
- Testing
- BREAST MILK, KNITTED OCTOPUS
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people
- Sponsor
- Pamukkale University
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