Clinical trials: Low; Birthweight
Premature Birth
Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
The aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos. To do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos…
- Trial name
- Petit-Poids (NCT06224764)
- Testing
- Mother and Father questionnaires
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hôpital NOVO
Low Birthweight, Preterm Birth
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or preterm (<37 weeks gestational age) infants admitted to…
- Trial name
- LIFT-UP (NCT06390943)
- Testing
- Facility-based feeding support package plus (FB-FSP+), Transition-to-home feeding support package plus (TTH-FSP+)
- Where
- 5 sites in India, Malawi and 1 more
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Breast-milk
Breast-milk Enema Administration to Stimulate Passage of Meconium
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP).
- Trial name
- BEAM (NCT07661992)
- Testing
- breast milk
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Wake Forest University Health Sciences
Prematurity
Dietary Protein in the Very-low-birth-weight Infant
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.
- Trial name
- NCT01208493
- Testing
- preterm infant formula with high protein levels, preterm standard infant formula
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Apnea of Prematurity
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal…
- Trial name
- NCT03298035
- Testing
- NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Prematurity; Extreme
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Preterm infants are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- PREM-GH (NCT07829562)
- Testing
- Golden hour
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Nutritional Status
Timing of Iron Supplementation in Very Low Birth Weight Infants
To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to…
- Trial name
- NCT00683527
- Testing
- Elemental iron
- Where
- India
- Volunteers
- 46 people
- Sponsor
- All India Institute of Medical Sciences
Gastric Tube Placement
Correct Gastric Tube Placement in Very Low Birth Weight Neonates
Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.
- Trial name
- NCT04127773
- Testing
- oro gastric tube
- Where
- Italy
- Volunteers
- 220 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Anemia, Iron-Deficiency
Iron Supplementation of Marginally Low Birth Weight Infants
Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (< 2500 g).
- Conditions
- Anemia, Iron-Deficiency, Child Behavior Disorders, Cognitive Manifestations
- Trial name
- JOHN (NCT00558454)
- Testing
- Iron
- Where
- 2 sites in Sweden
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Umeå University
Premature Birth, Infant, Extremely Low Birth Weight
Additional Protein Fortification in Extremely Low Birth Weight Infants
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
- Conditions
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- Trial name
- PROTSUP (NCT02515266)
- Testing
- nutrition: protein intake
- Volunteers
- 152 people
- Sponsor
- Hôpital de la Croix-Rousse
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.
Neonatology
Vermont Oxford Network Very Low Birth Weight Database
Vermont Oxford Network maintains a database for live born infants <=1500 grams or <=29 weeks gestational age who are born at participating hospitals or admitted to them within 28 days of birth, regardless of where in the hospital…
- Trial name
- VON VLBW (NCT01825499)
- Testing
- Registry
- Where
- United States
- Volunteers
- 60,000 people
- Sponsor
- Vermont Oxford Network
Preterm Birth, Retinopathy of Prematurity
Vitamin A and Very Low Birthweight Babies (VitAL)
Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs.
- Trial name
- NCT00417404
- Testing
- Aquasol A
- Where
- 2 sites in United Kingdom
- Volunteers
- 94 people
- Sponsor
- Glasgow Royal Infirmary
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
Respiratory Distress Syndrome, Newborn
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs.
- Trial name
- NCT05399628
- Testing
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter, Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Sepsis
Impact of Heart Rate Characteristics Monitoring in Neonates
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.
- Trial name
- HeRO (NCT00307333)
- Testing
- HeRO heart rate characteristics monitor
- Where
- 8 sites in United States
- Volunteers
- 3,003 people
- Sponsor
- University of Virginia
Respiratory Distress Syndrome, Newborn, Respiratory Tract Diseases
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal…
- Trial name
- NCT02340299
- Testing
- nHFOV, nCPAP
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Charite University, Berlin, Germany
Birth Asphyxia, Very Low Birth Weight Baby
Naushero Feroze Neonatal Survival Project
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Trial name
- AKU (NCT01350765)
- Testing
- Intervention, Control
- Where
- Pakistan
- Volunteers
- 37,201 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Preterm, Low Birthweight
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh.
- Conditions
- Preterm, Low Birthweight, Hypothermia Neonatal
- Trial name
- NCT06277843
- Testing
- Thermal Jacket
- Where
- Bangladesh
- Volunteers
- 10 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh