Atopy Clinical Trial - Microbiome, Atopic Disease, Prematurity

Status Active, not recruiting

Clinical Trial Summary

There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies. Our specific aims are: 1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics. 2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns. 3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age. The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04835935
Study type	Observational
Source	University of California, San Diego
Contact
Status	Active, not recruiting
Phase
Start date	June 1, 2019
Completion date	June 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03670732` - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure	N/A
Completed	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Recruiting	`NCT04542096` - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting	`NCT04911452` - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants	N/A
Recruiting	`NCT02901652` - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome	N/A
Completed	`NCT02148965` - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial	N/A
Completed	`NCT02273843` - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	Phase 1
Terminated	`NCT02032511` - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)	N/A
Completed	`NCT01721629` - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants	N/A
Terminated	`NCT01819532` - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks	N/A
Completed	`NCT00951860` - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort	N/A
Completed	`NCT01523769` - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants	N/A
Completed	`NCT01478711` - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Completed	`NCT00749008` - Study of Generalized Movements for Early Prediction of Cerebral Palsy	N/A
Terminated	`NCT00486395` - Will CPAP Reduce Length Of Respiratory Support In Premature Infants?	Phase 3
Completed	`NCT00527956` - Facilitation and Barriers to Breastfeeding in the NICU	N/A
Terminated	`NCT01208493` - Dietary Protein in the Very-low-birth-weight Infant	N/A
Completed	`NCT03372590` - NEO Rehab for Infants at Risk of Cerebral Palsy	N/A
Completed	`NCT00033917` - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Microbiome, Atopic Disease, Prematurity — MAP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms