Clinical trials: Infant, Late
Neonatal Hypoglycemia, Infant, Small for Gestational Age
Effect of Tahneek on Hypoglycemia in Newborn Infants
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth.
- Conditions
- Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction
- Trial name
- THIN (NCT03726697)
- Testing
- Tahneek
- Where
- Saudi Arabia
- Volunteers
- 324 people
- Sponsor
- King Abdullah International Medical Research Center
Iron Deficiency, Anemia of Prematurity
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.
- Trial name
- NCT00458068
- Testing
- Oral administration of ferrous sulphate
- Where
- Germany
- Volunteers
- 126 people
- Sponsor
- University of Ulm
Neonatal Late Onset Sepsis
Pentoxifylline Dose Optimization in Neonatal Sepsis
Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX).
- Trial name
- NCT04152980
- Testing
- Pentoxifylline
- Where
- 2 sites in Netherlands, Poland
- Volunteers
- 30 people
- Sponsor
- Erasmus Medical Center
Small for Gestational Age at Delivery, Gestational Diabetes
The CanDo (Canadian Donor Milk) Trial
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units.
- Conditions
- Small for Gestational Age at Delivery, Gestational Diabetes, type1diabetes, Type2diabetes
- Trial name
- NCT06315127
- Testing
- Human donor milk, Formula
- Where
- 3 sites in Canada
- Volunteers
- 112 people
- Sponsor
- Mount Sinai Hospital, Canada
Neurophysiologic Maturation
Neurophysiological Maturation Correlate With Clinical Milestones
To examine the association of early measures of heart rate variability and amplitude-integrated electroencephalography with time to wean to crib and to achieve full oral feeds among moderate and late preterm infants.
- Trial name
- NEMO (NCT03722901)
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Streptococcus Agalactiae
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age…
- Trial name
- NCT01888471
- Testing
- Blood sample, Vaginal swab sample
- Where
- South Africa
- Volunteers
- 3,033 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preterm Birth
The GROWNDUP Study of Late Preterm Births
This pilot study will examine the feasibility of conducting a large randomized clinical trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing complications among late preterm infants (LPTB), born…
- Trial name
- GROWNDUP (NCT01747603)
- Testing
- Specialized LPTB clinic
- Where
- 2 sites in Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- McMaster University
Preterm Birth
Initial Oxygen Concentration at Birth in Late-Preterm Infants
This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth.
- Trial name
- OXY-PREEM (NCT07315594)
- Testing
- 60% Oxygen Group - Infants will start in 60% oxygen, 30% Oxygen Group - Infants will start in 30% oxygen
- Where
- Canada
- Volunteers
- 1,520 people
- Sponsor
- University of Alberta
Patent Ductus Arteriosus, Prematurity
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of…
- Trial name
- NCT00833365
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Vaginal Infection, Pregnancy Complications
Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy
In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy.
- Conditions
- Vaginal Infection, Pregnancy Complications, Neonatal Sepsis, GBS
- Trial name
- NCT03008421
- Testing
- Astarte® (HSO Health Care GmbH, Vienna, Austria)
- Where
- Austria
- Volunteers
- 1,058 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
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.
Intraventricular Hemorrhage, Hydrocephalus
Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants
Intraventricular hemorrhage remains the most frequent, severe neurological complication of prematurity, occurring in 25-30% of preterm infants.
- Trial name
- LETAP (NCT00875758)
- Testing
- Removal of CSF through ventricular access device, Removal of CSF through a ventricular access device
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Washington University School of Medicine
Premature Baby 33 to 36 Weeks, Mother-Infant Interaction
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress.
- Conditions
- Premature Baby 33 to 36 Weeks, Mother-Infant Interaction, Oxidative Stress
- Trial name
- PRCTS2S (NCT04368767)
- Testing
- Skin-to-skin
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Preterm Birth, Mother-Infant Interaction
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants.
- Conditions
- Preterm Birth, Mother-Infant Interaction, Infant Development
- Trial name
- COSY (NCT05975203)
- Testing
- skin-to-skin contact
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University of Cologne
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Postpartum Depression, Preterm Infant
The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
Preterm birth is a serious public health issue, affecting 10% of all births in the US alone. Three quarters of these infants are born between 34 0/7 and 36 6⁄7 weeks' gestation or late-preterm (LP).
- Conditions
- Postpartum Depression, Preterm Infant, Infant Development
- Trial name
- BabyAMOR (NCT03836430)
- Testing
- Newborn Behavioral Observation-Family Wellness (NBO-FW)
- Where
- United States
- Volunteers
- 208 people
- Sponsor
- Brigham and Women's Hospital
Late Preterm Infant
Feeding and Wellness Among Late Preterm Infants
1. The first aim of this proposal is to pilot the feasibility of weekly phone monitoring of infant feeding and illness patterns in a socio-economically and racially diverse population.
- Trial name
- NCT00470717
- Testing
- Weekly telephone call
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University Hospitals Cleveland Medical Center
Premature Birth
Fathers and Late Preterm Babies Study
The purpose of this study is to test an educational intervention for first-time fathers of late preterm (34 to 36 weeks gestation) infants.
- Trial name
- FLPTB (NCT01056653)
- Testing
- Standard Dose, High Dose, Comparison Group
- Where
- Canada
- Volunteers
- 113 people
- Sponsor
- University of Calgary