Treatment Trials

32 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
Description

A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.

RECRUITING
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
Description

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

Conditions
COMPLETED
Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
Description

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

COMPLETED
Healthy Term Infants Fed Milk-Based Infant Formula
Description

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Conditions
COMPLETED
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Description

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

COMPLETED
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Description

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Conditions
TERMINATED
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Description

This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.

COMPLETED
Growth and Safety Study of an Infant Formula for Healthy Term Infants
Description

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

WITHDRAWN
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
Description

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Conditions
COMPLETED
Soy Formula Feedings in Healthy, Term Infants
Description

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

COMPLETED
Growth of Healthy Term Infants Fed Formula Containing DHA-B
Description

The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.

TERMINATED
Healthy Term Infants Fed Milk-Based Formulas
Description

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Conditions
COMPLETED
Healthy Term Infants Fed Milk-Based Formulas
Description

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

COMPLETED
Tolerance of Healthy Term Infants Fed Infant Formulas #4
Description

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

TERMINATED
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Description

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

COMPLETED
Tolerance of Healthy Term Infants Fed Infant Formulas #3
Description

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

COMPLETED
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
Description

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Conditions
COMPLETED
Tolerance of Healthy Term Infants Fed Infant Formulas
Description

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Conditions
COMPLETED
Tolerance of Healthy, Term Infants to Infant Formulas
Description

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Conditions
COMPLETED
Tolerance and Development of Healthy, Term Infants
Description

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Conditions
COMPLETED
The Evaluation of Cow's Milk Formula - Study B
Description

A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat

COMPLETED
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Description

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.

COMPLETED
Growth and Safety of a Low Lactose Milk-Based Infant Formula
Description

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

COMPLETED
First Complementary Foods and the Infant Gastrointestinal Microbiota
Description

This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.

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
Gastrointestinal Tolerance Evaluation of an Infant Formula
Description

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

COMPLETED
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
Description

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

UNKNOWN
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
Description

Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life. Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels. Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.

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
Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up
Description

Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT 2)-Long Term Follow-up will follow participants enrolled in the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) (NCT01167270) study from age 3 years through the developmentally important time at school-entry around age 6 years and into middle childhood at age 9.

Conditions