Prematurity Clinical Trial
Official title:
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
The proposed study will address our novel hypothesis that maternal stress is associated with feeding outcomes and markers of impaired neurodevelopment for preterm infants and alters human milk and infant gut profiles in ways that affect preterm neurodevelopment. Mothers and their preterm infants (28-34 weeks gestation at birth) will be recruited to determine if: (1) variation in postnatal stress among mothers of very preterm infants relates to the total volume or proportion of maternal milk provided to her infant in the NICU and if (2) variation in maternal postnatal stress relates to her preterm infant's neurocognitive status at NICU discharge and 4 months corrected age. This project also involves collection/storage of maternal milk and infant fecal samples for multi-omics analyses. More specifically, the study will address: (3A) Is maternal postnatal stress associated with the metabolomic and microbiome characteristics of the infant's gut and/or the milk composition?, and (3B) Do milk composition differences relate to infant neurodevelopment? The aims of the proposed study contribute to our overarching research goal, which is to improve neurodevelopmental health for preterm infants by building the health and resilience of the mother-milk-infant triad. ;
| 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 |
NCT00749008 -
Study of Generalized Movements for Early Prediction of Cerebral Palsy
|
N/A | |
| Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
| Completed |
NCT00527956 -
Facilitation and Barriers to Breastfeeding in the NICU
|
N/A | |
| Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
| 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 |