Clinical trials: Preterm Infants
Respirtory Distress
Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion…
- Trial name
- NCT02421328
- Testing
- CPAP first (Fisher & Paykel Healthcare), HHHFNC first (Fisher & Paykel Healthcare)
- Where
- 2 sites in Egypt
- Volunteers
- 24 people
- Sponsor
- Mansoura University Children Hospital
Retinopathy of Prematurity
umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)
Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients.
- Trial name
- BORN (NCT05100212)
- Testing
- cord blood-RBC concentrates, adult donor RBC concentrates
- Where
- 10 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prolonged Apnea, Prolonged Bradycardia
DTaP and Apnea/Bradycardia in Preterm Infants
The purpose of this study is to examine the relationship between receipt of DTaP and the occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing a random control study design and an objective…
- Trial name
- PIA (NCT00482781)
- Testing
- Infanrix, Pediatrix
- Where
- 10 sites in United States
- Volunteers
- 191 people
- Sponsor
- American SIDS Institute
Growth Failure, Preterm Birth
Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation).
- Conditions
- Growth Failure, Preterm Birth, Microbiota
- Trial name
- IOCOIOPGIPI (NCT07082881)
- Testing
- Colostrum, Normal Saline
- Volunteers
- 220 people
- Sponsor
- Suqian First Hospital
Cerebral Palsy, Infant Development
Associations Between General Movements Assessments and Cognitive Development
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant Development, Cognitive Dysfunction, Cognitive Developmental Delay
- Trial name
- GMs (NCT05217056)
- Testing
- measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Low Birth Weight Infant, Enteral Nutrition
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims…
- Trial name
- SROPREMA (NCT00715000)
- Testing
- Oral rehydration therapy, classical hydration via intravenous infusion
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Retinopathy of Prematurity
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure.
- Trial name
- NCT01872871
- Testing
- Paracetamol
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Immune System Disorder, Preterm
Preterm Immune System Development and Response to Immunization
In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.
- Conditions
- Immune System Disorder, Preterm, Vaccination Failure
- Trial name
- PRIMI (NCT05266664)
- Where
- 7 sites in Netherlands
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Infant, Premature, Hypoperfusion in Newborn
Monitoring of Systemic or Organ Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants.
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- Trial name
- NCT03136172
- Testing
- NIRS (near Infra-red spectroscopy)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Inha University Hospital
Necrotizing Enterocolitis
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
- Trial name
- NCT00252681
- Testing
- laparotomy, primary peritoneal drainage
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Yale University
Osteopenia of Prematurity
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT01042639
- Testing
- passive physical activity
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Meir Medical Center
Respiratory Distress Syndrome in Preterm Infants
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown.
- Trial name
- NCT05388175
- Testing
- Rigid catheter, Soft catheter
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Respiratory Insufficiency of Prematurity
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD).
- Trial name
- NIPPV (NCT00433212)
- Testing
- nCPAP, NIPPV
- Where
- 35 sites in United States, Austria and 8 more
- Volunteers
- 1,011 people
- Sponsor
- McMaster University
Prematurity, Iron-deficiency
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency…
- Conditions
- Prematurity, Iron-deficiency, Iron Deficiency Anemia, Iron Malabsorption
- Trial name
- DIVI (NCT05340465)
- Testing
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Washington
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
- Trial name
- NCT00658905
- Testing
- rhBSSL
- Where
- 6 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Infant, Premature, Diseases
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies
Alterations to microvascular blood flow in premature infants, are known to contribute to several major disease entities. The optically-measured tissue blood flow, to determine tissue perfusion that can be use to detect blood loss.
- Trial name
- NCT01982357
- Testing
- Laser Speckle Imaging and Diffuse Optical Spectroscopy
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of California, Irvine
Retinopathy of Prematurity
Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity
To evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. In addition risk factors for the development of ROP will be checked.
- Trial name
- NCT00339001
- Testing
- erythropoietin and early iron supplements
- Where
- Israel
- Volunteers
- 400 people
- Sponsor
- Sheba Medical Center
Prematurity, Nephrocalcinosis
Preterm Infants and Nephrocalcinosis
Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born prematurely and with very low birth weight…
- Conditions
- Prematurity, Nephrocalcinosis, Hypercalciuria
- Trial name
- NC (NCT02438267)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Utah
Ventilator Lung; Newborn
NIPE as an Indicator of Pain in Sedated/Ventilated Patient Under 3 Years-old Hospitalized in Intensive Care Unit
The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric…
- Trial name
- NIPE (NCT04195672)
- Testing
- NIPE (MDoloris®) and CBS values
- Where
- France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Lille
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