Clinical trials: Infant,Premature
Preterm Infant, Development, Infant
Prebiotic in Preterm Infants
This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18…
- Conditions
- Preterm Infant, Development, Infant, Nutrition
- Trial name
- NCT03306316
- Testing
- Prebiotic, Dextrose Control
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Nationwide Children's Hospital
Respiratory Distress Syndrome, Hyaline Membrane Disease
Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS
The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation…
- Trial name
- NCT02482766
- Testing
- Poractant alfa, 200 mg/kg, Ventilator for High-frequency Oscillatory Ventilation (HFOV), Nasal Continuous Positive Airway Pressure (nCPAP)
- Where
- 33 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Catholic University of the Sacred Heart
Oral Disorders
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain…
- Trial name
- ORAPREM (NCT06648083)
- Testing
- Food autonomy
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Hospices Civils de Lyon
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Other Preterm Infants
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and…
- Trial name
- NCT02231801
- Testing
- Mother-Infant Dyad
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Term Infant, Late Preterm Infant
Brain Uptrain to Improve Learning and Development
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age.
- Trial name
- BUILD (NCT06638801)
- Testing
- Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- University of Alabama at Birmingham
Preterm Birth, Early Intervention
Movement Imitation Therapy for Preterm Babies (MIT-PB) - A Pilot Study
Background: Very preterm babies are at high risk for developmental disorders. Prechtl's General Movements (GMs) Assessment is a valuable and reliable tool in infants until three months corrected age for predicting their further…
- Conditions
- Preterm Birth, Early Intervention, General Movements
- Trial name
- NCT07449312
- Testing
- Movement Imitation Therapy for Preterm Babies (MIT-PB), Usual care Physiotherapy
- Where
- Switzerland
- Volunteers
- 80 people
- Sponsor
- University of Zurich
Intraventricular Hemorrhage, Periventricular Leukomalacia
Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later…
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Renal Injury
- Trial name
- NCT02221219
- Testing
- Indomethacin, delay in umbilical cord clamp at birth, immediate cord clamp at birth
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Hong Huang
Liver Disease
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates.
- Trial name
- NCT02947594
- Volunteers
- 37 people
- Sponsor
- Università Politecnica delle Marche
Neonates or Premature Babies, Parent
Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit
This is a pre/post quasi-interventional study with two arms. First, a baseline cohort of parent-infant dyads admitted to the Neonatal Intensive Care Unit (NICU) were enrolled and surveyed at three timepoints (admission…
- Conditions
- Neonates or Premature Babies, Parent, Reading, NICU Infants
- Trial name
- NCT07511075
- Testing
- Shared reading program
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Catherine Caruso
Kangaroo-mother Care
Skin-to-skin Contact Between Premature Infant and Mother
Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days.
- Trial name
- NCT06380231
- Testing
- kangaroo mother care (KMC)
- Where
- Turkey (Türkiye)
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Istanbul Rumeli University
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Apnoea, Prematurity
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
The aim of this study is to monitor the frequency of apnoeas (pauses in breathing) on various methods of non-invasive respiratory support that are detected by an automated machine-learning (ML) model based on diaphragmatic…
- Trial name
- NCT07794007
- Testing
- Diaphragmatic electromyography
- Volunteers
- 30 people
- Sponsor
- King's College Hospital NHS Trust
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
Pain, Infant, Premature, Diseases
Continuous Infusion of Fentanyl in Preterm on MV
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV: Group A) continuous…
- Conditions
- Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
- Trial name
- NCT00571636
- Testing
- Fentanyl, 5% glucose solution
- Where
- Italy
- Volunteers
- 128 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Tissue Oxygenation
The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause…
- Trial name
- TCBTOUNACOIVPI (NCT06483867)
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- The First Hospital of Jilin University
Intraventricular Hemorrhage of Prematurity, Nursing Caries
Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
Existing measures to prevent intraventricular hemorrhage in preterm infants include preventing premature delivery, pre-natal administration of corticosteroid, active treatment of chorioamnionitis, and improvement of postnatal…
- Trial name
- NCT05844709
- Testing
- IVH care Bundle
- Where
- Taiwan
- Volunteers
- 178 people
- Sponsor
- National Taiwan University Hospital
Virtual Reality, Breast Milk Expression
Breast Milk Expression With Virtual Reality
The study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's breast milk expression experience, transition process, and milk…
- Trial name
- NCT06164223
- Testing
- VR Baby Pump
- Where
- Turkey (Türkiye)
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Akdeniz University
Premature Birth
Neonatal Resuscitation - Sustained Inflations
This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.
- Trial name
- NCT02967562
- Testing
- Inflation Breaths, Sustained Inflation
- Where
- United Kingdom
- Volunteers
- 63 people
- Sponsor
- King's College London