Clinical trials: Premature Infant
Dolichocephaly
Cranial Cup Use for Correction of Head Shape Deformities
The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying…
- Trial name
- NCT01683812
- Testing
- Cranial Cup
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Boston Children's Hospital
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Respiratory Distress Syndrome, Newborn
Comparison of CPAP Machines With Reusable vs Disposable Circuits
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress…
- Trial name
- NCT03121612
- Testing
- CPAP
- Where
- India
- Volunteers
- 51 people
- Sponsor
- Medical Technology Transfer and Services Hong Kong Ltd
Infant,Premature
Improving Right Ventricular Function in Young Adults Born Preterm
The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.
- Trial name
- NCT03696758
- Testing
- Pulmonary Function Testing, Electrocardiogram, Cardiac Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
- Trial name
- NCT05949788
- Testing
- No intervention
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Premature Birth, Neonatal Hypoxic Conditions
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
- Trial name
- Vanilla (NCT02630147)
- Testing
- Vanilla scent
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Université de Sherbrooke
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Infant,Premature, Feeding; Difficult, Newborn
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction.
- Trial name
- NCT03280381
- Testing
- Nifty feeding cup, Generic medicine cup
- Where
- Ghana
- Volunteers
- 200 people
- Sponsor
- PATH
Premature Infants
Clinical Experience With Numeta in Preterm Infants
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition.
- Trial name
- Numeta (NCT01981057)
- Testing
- Numeta, Individual
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Premature Birth of Newborn
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Premature infants sometimes require sedation to ensure minimal movement during diagnostic procedures such as MRIs. However, sedatives may produce adverse effects.
- Trial name
- NCT01354028
- Testing
- Massage therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas
Respiratory Tract Infection, Respiratory Syncytial Virus
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational…
- Trial name
- NCT03524118
- Testing
- Clesrovimab
- Where
- 34 sites in United States, Chile and 4 more
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one…
- Trial name
- Fenaki (NCT02620761)
- Testing
- Fenoldopam, 0.9%NS
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Retinopathy of Prematurity, Neonatal Cholestasis
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency.
- Trial name
- NCT01875510
- Testing
- Fish-oil emulsions, soybean-oil emulsion
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Dr. Sami Ulus Children's Hospital