Treatment Trials

9 Clinical Trials for Various Conditions

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COMPLETED
Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Description

Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry, respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of life; beyond the initial 5minutes of life, monitoring as well as infant's management will be done as per current Weiler hospital protocols. The intervention group will be placed in prone position for first five minutes immediately after birth, and then changed to supine position. The control group will be placed supine from birth. Investigators will check for the incidence and severity of RD, supplemental oxygen need and duration, positive pressure ventilation (PPV) need and duration or other use of respiratory support (intubation). Additionally, investigators will record the number of infants requiring admission to the NICU in each group, days of ventilatory support as well as the length of hospitalization.

COMPLETED
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Description

* Exploratory analyses of the immune response in a ex vivo culture system * Characterization of the composition of maternal milk and infant urine

COMPLETED
Brain Structure and Development in Pre-Term and Full-Term Infants
Description

The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.

Conditions
COMPLETED
Gastrointestinal Tolerance Evaluation of an Infant Formula
Description

Prospective, double-blind, randomized study of 2 infant formulas.

COMPLETED
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
Description

Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. The central hypothesis of this proposal is that intrauterine exposure to benzo\[a\]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The goals of this proposal are to: 1) determine benzo\[a\]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo\[a\]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo\[a\]pyrene exposure programs metabolic disease through alterations in DNA methylation and gene expression, and 4) determine the plasticity of the DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of this project is to define biomarkers that identify neonates at "high-risk" for diminished attainment of full health potential, who can then be targeted for preventative measures.

COMPLETED
A Novel Parent Education Program for Early Intervention
Description

One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.

COMPLETED
Thyroid Function in Term Infants With Respiratory Distress
Description

This study was designed to evaluate the level of certain hormones (thyroid hormones and cortisol) in full term or close to full term infants who have respiratory distress severe enough to require respiratory support. The purpose of this study is to determine if there is a relationship between these hormone levels and how sick these infants are who require help with breathing following birth. Hypothesis: Infants who are born full term or near full term and who have low hormone levels will have higher severity of illness.

TERMINATED
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Description

OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

COMPLETED
Probiotic Formula and Infant Growth
Description

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Conditions