Clinical trials: Low; Birthweight
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
Infant, Very Low Birth Weight, Infant, Premature
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22…
- Conditions
- Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
- Trial name
- TIPP (NCT00009646)
- Testing
- indomethacin
- Where
- 9 sites in United States
- Volunteers
- 1,202 people
- Sponsor
- NICHD Neonatal Research Network
Early Intervention, Low Birth Weight Infants
The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant
This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.
- Conditions
- Early Intervention, Low Birth Weight Infants, Term Infants
- Trial name
- NCT04313478
- Testing
- Low Birth Weight and Normal Weight infants
- Volunteers
- 85 people
- Sponsor
- Istanbul Medipol University Hospital
Prematurity
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors.
- Trial name
- NCT01776268
- Testing
- Oral priming
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Vanderbilt University Medical Center
Malaria, Low Birth Weight
Malaria in Pregnancy: Nutrition and Immunologic Effects
The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.
- Conditions
- Malaria, Low Birth Weight, Anemia, Perinatal Mortality
- Trial name
- MAL2 (NCT01115478)
- Testing
- Vitamin A, Zinc
- Where
- Tanzania
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Neonatal Hypothermia
Hypothermia Prevention in Low Birthweight and Preterm Infants
Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually.
- Trial name
- NCT04364204
- Testing
- Kangaroo Mother Care and BEMPU bracelet, Kangaroo Mother Care
- Where
- 6 sites in Ghana
- Volunteers
- 380 people
- Sponsor
- University of South Carolina
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
Periodontal Disease, Preterm Birth
Periodontal Disease and Preterm Birth
To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or…
- Conditions
- Periodontal Disease, Preterm Birth, Low Birth Weight
- Trial name
- NCT00582374
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Oklahoma
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
Infant, Newborn, Respiratory Distress Syndrome
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection.
- Conditions
- Infant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency
- Trial name
- Surfactant 2 (NCT00005774)
- Testing
- Early surfactant, Standard practice
- Where
- 13 sites in United States
- Volunteers
- 61 people
- Sponsor
- NICHD Neonatal Research Network
Malaria, Pregnancy
Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy
The incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with…
- Conditions
- Malaria, Pregnancy, Anaemia
- Trial name
- IPTp_IST (NCT01084213)
- Testing
- Intermittent screening and treatment of malaria in pregnancy (IST), SP-IPTp
- Where
- 4 sites in Burkina Faso, Ghana and 2 more
- Volunteers
- 5,354 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Necrotizing Enterocolitis
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control…
- Trial name
- ECUN-2 (NCT04584320)
- Testing
- Stool sample
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Staphylococcal Infections
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
- Trial name
- NCT00066989
- Testing
- Staphylococcus aureus Immune Globulin (Human) 5%
- Volunteers
- 200 people
- Sponsor
- Nabi Biopharmaceuticals
Prematurity, Oxidant Injury
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and…
- Trial name
- NCT00369720
- Testing
- Titration of oxygen in delivery room
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Neil Finer
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
Infant, Extremely Low Birth Weight, Microcephaly
Summary of Infants Weighing 500 Grams or Less
This is a retrospective single-center cohort study. The comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.
- Trial name
- NCT05322980
- Testing
- Microcephaly
- Where
- Japan
- Volunteers
- 22 people
- Sponsor
- Nagano Children's Hospital
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.
Neonatal Sepsis, Low Birth Weight
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000…
- Trial name
- NCT00947518
- Testing
- Chlorhexidine, Normal saline
- Volunteers
- 60 people
- Sponsor
- All India Institute of Medical Sciences