Clinical trials: Premature Neonates
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Suspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery, Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood Products
The Use of Lung Ultrasonography in the Delivery Room in Neonates
Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method.
- Trial name
- LUSIN (NCT06314789)
- Testing
- doing lung ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Kırıkkale University
Newborn; Vitality, Nursing Caries
Effect of Intranasal Breast Milk Administration in Preterm Infants
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Trial name
- NCT06706115
- Testing
- Intranasal human breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Acute Kidney Injury
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates
Introduction: Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse…
- Trial name
- AWAKEN (NCT02443389)
- Where
- United States
- Volunteers
- 2,186 people
- Sponsor
- University of Alabama at Birmingham
Bronchopulmonary Dysplasia
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines .
- Trial name
- NCT01373008
- Testing
- Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Bnai Zion Medical Center
Procedural Pain
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation…
- Trial name
- NCT07190625
- Testing
- fentanyl intravenous, Fentanyl intranasal using atomizer, fentanyl intranasal direct
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Ain Shams University
Patency of the Ductus Arteriosus, Acetaminophen
Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth.
- Conditions
- Patency of the Ductus Arteriosus, Acetaminophen, Extreme Prematurity
- Trial name
- TREOCAPA (NCT04459117)
- Testing
- Acetaminophen, NACL 0.9%
- Where
- 36 sites in Belgium, Denmark and 10 more
- Volunteers
- 804 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation.
- Conditions
- Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA)
- Trial name
- VEEP (NCT07273643)
- Testing
- Venous Cord blood sample, Arterial cord blood sample
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
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
Retinopathy of Prematurity
Use of Pan-vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)
The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for…
- Trial name
- NCT00870636
- Testing
- Bevacizumab (Avastin)
- Where
- United States
- Sponsor
- Children's Hospital Los Angeles
Neonatal Intensive Care Unit, PreTerm Neonate
Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
This study evaluates the effects of a Structured Maternal Voice Program (SMVP). on premature infant responses and maternal-infant attachment in the intensive care unit (NICU) .
- Conditions
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- Trial name
- SMVP-NICU (NCT06839534)
- Testing
- Structured Maternal Voice Program (SMVP)
- Where
- Thailand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Simulator Training, Neonates and Preterm Infants
Neonatal Umbilical Catheter Pathway Simulator
Currently, training for umbilical catheter placement in neonates is primarily focused on inserting the catheter into the umbilical vein.
- Conditions
- Simulator Training, Neonates and Preterm Infants, Catherization
- Trial name
- NeoPath (NCT07142434)
- Testing
- neonatal Umbilical Catheter Pathway Simulator
- Volunteers
- 25 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Respiratory Distress Syndrome
Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with…
- Trial name
- NCT01923844
- Testing
- exogenous surfactant
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Ege University
Kangaroo Care, Fathers
The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs
This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to…
- Conditions
- Kangaroo Care, Fathers, Mother-Infant Interaction, Premature Infant
- Trial name
- NCT06320587
- Testing
- Kangaroo care practice by both mother and father, Kangaroo care practice only mother
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Neonatal Infection, Neonatal Necrotizing Enterocolitis
Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT.
- Trial name
- NCT01729000
- Testing
- Gloves
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- University of Virginia
Procedural Pain, Preterm Infants
Effectiveness of Gentle Touch Technique on Pain Level During Painful Procedures in Preterm Infants
Preterm infants in neonatal intensive care units frequently undergo painful procedures that may affect their physiological stability, including pain level and respiratory parameters.
- Trial name
- NCT07470398
- Testing
- Gentle Touch Technique
- Where
- 3 sites in Iraq
- Volunteers
- 60 people
- Sponsor
- Karbala University
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Infant, Premature, Diseases
Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning
To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.
- Trial name
- NCT02668107
- Testing
- Hammock positioning
- Where
- Brazil
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Preterm Infants
Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants
Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT07522892
- Testing
- Swaddle Bathing, Conventional Tub Bathing
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- Chang Gung University of Science and Technology
Neonatal Respiratory Distress Syndrome, Inflammatory Response
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.
- Conditions
- Neonatal Respiratory Distress Syndrome, Inflammatory Response, Premature Lungs, Neutrophil Extracellular Trap Formation
- Trial name
- NCT06367881
- Testing
- Alveofact, Budesonide
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
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