Clinical trials: Very Preterm Infant
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
Infant, Premature
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU).
- Trial name
- NCT02848755
- Testing
- Cranial ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 341 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Premature Birth
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
- Trial name
- NCT02628015
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Partial Mineralocorticoid Deficiency
Impact of the Administration of Fludrocortisone in Very Premature Infants
Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway (renin-angiotensin-aldosterone system acting on the renal tubule).
- Trial name
- MINIPREM (NCT03001089)
- Testing
- Oral Fludrocortisone (enteral)
- Where
- France
- Volunteers
- 66 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Preterm Infants
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.
- Trial name
- NCT04277806
- Testing
- New Oral feeding process
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Children's Hospital of Fudan University
Bronchopulmonary Dysplasia, Retinopathy of Prematurity
Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity
Background: Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes, respectively.
- Conditions
- Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Prematurity, Pulmonary Disease
- Trial name
- NCT01780155
- Where
- 8 sites in United States, Argentina
- Volunteers
- 1,068 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Very Low Birth Weight Infant
Comparison of Early Versus Late Trophic Feeding
Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce.
- Trial name
- NCT07229885
- Testing
- Early trophic feeding, Late trophic feeding
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- RESnTEC, Institute of Research
Infant, Premature, Nutrition, Enteral
Aspiration of Residual Gastric Contents
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
- Trial name
- NCT01863043
- Testing
- No aspiration of gastric contents, Routine aspiration of gastric contents
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- University of Florida
Other Preterm Infants, NEC
Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study
This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight…
- Trial name
- NCT02192996
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Hospital Universitario La Paz
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Motor Development of Premature Infants
Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
Infants born very premature have biological risk factors for later developmental coordination disorder. Parental stereotyping of infants as fragile and other environmental factors, such as spending long periods laying on their…
- Trial name
- HOP-ON (NCT01281358)
- Testing
- HOP-ON, SMILES
- Where
- 3 sites in United Kingdom
- Volunteers
- 160 people
- Sponsor
- University of Nottingham
Preterm Infants
Bifidobacterium Supplementation for Very Low Birth Weight Infants
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum…
- Trial name
- Bifido(RCT) (NCT01375309)
- Testing
- Bifidobacterium bifidum supplementation
- Where
- Japan
- Volunteers
- 246 people
- Sponsor
- Tokyo Women's Medical University
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
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
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
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
Infant, Very Low Birth Weight
High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants
The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low…
- Trial name
- NCT03374033
- Testing
- NUTR +, STIMUL +
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Università Politecnica delle Marche
Nutrition Disorder, Infant
Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants
A single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was…
- Trial name
- PUMPA (NCT04085484)
- Testing
- More concentrated parenteral nutrition solution
- Where
- Sweden
- Volunteers
- 134 people
- Sponsor
- Umeå University
BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis
Targeted vs Standard Fortification of Breast Milk
BACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW.
- Conditions
- BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis, Weight Gain, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT03775785
- Testing
- Tailored enteral nutrition
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland