Clinical trials: Very Preterm Birth
Preterm Birth
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation.
- Trial name
- NCT00128141
- Testing
- Tactile stimulus
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- National Bioethics Commission of Brazil
Respiratory Distress Syndrome, Newborn
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always…
- Trial name
- NCT02267018
- Testing
- Drager VN500 Ventilator
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Prematurity, VLBW - Very Low Birth Weight Infant
Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss.
- Trial name
- NCT03884322
- Testing
- Prepod, Joint compression exercises
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Asante Health System
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
Preterm Infant, Cerebral Palsy
Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention
Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities.
- Trial name
- TimeSPEEDI2 (NCT03518736)
- Testing
- Supporting Play Exploration and Developmental Intervention (SPEEDI)
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- University of Southern California
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
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
USCOM Parameters in Preterm Infants: Reference Ranges
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants.
- Trial name
- NCT05961657
- Testing
- Hemodynamic measurements by USCOM
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
Preterm Infants, Respiratory Distress Syndrome
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard…
- Conditions
- Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula
- Trial name
- NCT03121781
- Testing
- respiratory support- interface
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Apnea of Prematurity
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system.
- Trial name
- CAP-S (NCT01020357)
- Testing
- Caffeine citrate injection
- Where
- 4 sites in Australia, Canada
- Volunteers
- 201 people
- Sponsor
- McMaster University
Sepsis, Length of Stay
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis…
- Conditions
- Sepsis, Length of Stay, Mortality, Neurodevelopmental Delay
- Trial name
- LET-FEED (NCT06893939)
- Testing
- Limited Trophic Feeds (1 day of trophic feeds), Extended Trophic Feeds (3 days of trophics)
- Where
- 6 sites in United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- University of Washington
Iron Deficiency Anemia
Donor Breast Milk 2
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol .
- Trial name
- NCT07816601
- Testing
- Ferrous Sulfate Oral Product
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- AdventHealth
Very Low Birth Weight Infants, Premature Infants
Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds.
- Conditions
- Very Low Birth Weight Infants, Premature Infants, Intraventricular Hemorrhage
- Trial name
- DCC (NCT02337088)
- Testing
- Delayed cord clamping at 30 seconds, Delayed cord clamping at 60 seconds
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Chicago
Skin to Skin, Premature Newborns
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants…
- Trial name
- TRANSPAPNEO (NCT05820386)
- Testing
- Skin-to-skin Contact (SSC), Incubator
- Where
- 4 sites in France
- Volunteers
- 118 people
- Sponsor
- University Hospital, Tours
Premature Infant, Non-invasive Respiratory Support
Feeding Premature Infants During Non-invasive Respiratory Support
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
- Trial name
- NCT03852641
- Testing
- Length of feeding
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
Trans Epidermal Water Loss (TEWL)
Effect of Coconut Oil Application in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness.
- Trial name
- TopOilTewl (NCT01364948)
- Testing
- Coconut oil application, No oil application
- Where
- India
- Volunteers
- 74 people
- Sponsor
- All India Institute of Medical Sciences
Intraventricular Hemorrhage (IVH), Bleeding in the Brain
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
- Conditions
- Intraventricular Hemorrhage (IVH), Bleeding in the Brain, Prematurity, Very Low Birth Weight Infants
- Trial name
- NCT00033917
- Testing
- indomethacin
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Yale University
Bronchopulmonary Dysplasia, Child Development
Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study
This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- NCT05915806
- Testing
- High-dose DHA, Control
- Where
- Canada
- Volunteers
- 1,801 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Premature Birth
Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
A video of the delivery room management will be taken using standardized conditions. The video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the…
- Trial name
- NCT01420107
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Medicine Greifswald
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
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute