Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Официальное название

Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Maternal milk production inpatient [Срок оценки: 28-35 weeks postmenstrual age]
• Maternal milk production 4 months corrected age [Срок оценки: 4 months corrected age]
• Maternal milk proportion inpatient [Срок оценки: 28-35 weeks postmenstrual age]
• Maternal milk proportion 4 months corrected age [Срок оценки: 4 months corrected age]
• Infant Neurodevelopment inpatient [Срок оценки: 35-37 weeks postmenstrual age]
• Infant Neurodevelopment 4 months corrected age [Срок оценки: 4 months corrected age]
• Infant Neurodevelopment 4 months corrected age [Срок оценки: 4 months corrected age]
• Infant gut microbiome inpatient [Срок оценки: 28-35 weeks postmenstrual age]
• Infant gut microbiome 4 months corrected age [Срок оценки: 4 months corrected age]
• Milk microbiome inpatient [Срок оценки: 28-35 weeks postmenstrual age]

Критерии участия

Критерии включения

• preterm infant born between 28 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
• mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery

Критерии исключения

• infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
• mothers: a) alcohol consumption >1 drink per week or any tobacco consumption during pregnancy, b) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT05537454 · SPH-2022-31233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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