Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/10/2018 |
| Start Date: | October 31, 2018 |
| End Date: | July 2019 |
| Contact: | Lisa F Brown, PhD, RN |
| Email: | lfbrown2@vcu.edu |
| Phone: | 804-335-9484 |
A majority of mothers experience high stress levels and associated symptoms of anxiety,
depressive symptoms, and sleep disruption during the NICU hospitalization and continuing
after hospital discharge. Given preterm infant feeding is one of the most stressful things
the new mother will face and given the harmful nature of stress on maternal and infant
health, it is important an intervention focuses on both of these concerns: infant feeding and
maternal stress. Therefore, the purpose of this research study is two-fold. First, the
investigators will examine how practical and acceptable it is for mothers of preterm infants
to participate in Stress And FEeding (SAFE) intervention and collect biological stress
measures from mothers and their preterm infant's saliva (spit). The intervention is designed
to reduce stress and improve maternal feeding interaction. The second purpose of this study
is to examine changes before and after using the intervention. The intervention will take
place over the infant's first 4-months corrected age (CA). CA is calculated by subtracting
the number of weeks born before 40-weeks of gestation from the number of weeks the infant has
been born.
depressive symptoms, and sleep disruption during the NICU hospitalization and continuing
after hospital discharge. Given preterm infant feeding is one of the most stressful things
the new mother will face and given the harmful nature of stress on maternal and infant
health, it is important an intervention focuses on both of these concerns: infant feeding and
maternal stress. Therefore, the purpose of this research study is two-fold. First, the
investigators will examine how practical and acceptable it is for mothers of preterm infants
to participate in Stress And FEeding (SAFE) intervention and collect biological stress
measures from mothers and their preterm infant's saliva (spit). The intervention is designed
to reduce stress and improve maternal feeding interaction. The second purpose of this study
is to examine changes before and after using the intervention. The intervention will take
place over the infant's first 4-months corrected age (CA). CA is calculated by subtracting
the number of weeks born before 40-weeks of gestation from the number of weeks the infant has
been born.
Descriptive statistics will be computed for demographic and outcome variables. The number of
mother/infant dyads recruited but not enrolled will be tracked. If provided, reasons for
non-participation will be noted. Enrolled dyads will be tracked and monitored for the number
of times the interventions are used and completeness of study data. Acceptability and burden
will be assessed by theme analysis of the responses to the interview by the mPI's using
traditional strategies of reading and re-reading the transcripts, coding participant
responses using their language, and developing categories and subcategories to create a
structure for considering acceptability will be completed.. Finally, perceptions of
usefulness and satisfaction of the mothers will be assessed by looking at frequencies of
Likert responses.
Means and standard errors of the maternal stress and feeding behavior variables will be
estimated and graphed across the data collection time points. Although the sample size is
small, it is anticipated the mixed effects linear model will be used to assess and quantify
changes across time. This model will include a random effect for participant and a fixed
effect for time. The model is flexible enough to model potential cofactors, such as age at
birth. The study will track the number of successfully obtained, transported, processed and
stored samples and compare those number to the proposed maternal and infant cortisol
collections.
mother/infant dyads recruited but not enrolled will be tracked. If provided, reasons for
non-participation will be noted. Enrolled dyads will be tracked and monitored for the number
of times the interventions are used and completeness of study data. Acceptability and burden
will be assessed by theme analysis of the responses to the interview by the mPI's using
traditional strategies of reading and re-reading the transcripts, coding participant
responses using their language, and developing categories and subcategories to create a
structure for considering acceptability will be completed.. Finally, perceptions of
usefulness and satisfaction of the mothers will be assessed by looking at frequencies of
Likert responses.
Means and standard errors of the maternal stress and feeding behavior variables will be
estimated and graphed across the data collection time points. Although the sample size is
small, it is anticipated the mixed effects linear model will be used to assess and quantify
changes across time. This model will include a random effect for participant and a fixed
effect for time. The model is flexible enough to model potential cofactors, such as age at
birth. The study will track the number of successfully obtained, transported, processed and
stored samples and compare those number to the proposed maternal and infant cortisol
collections.
Maternal Inclusion Criteria:
- English-speaking and reading
- Given birth to preterm infant < 35-weeks gestation
- Has access to internet
- Lives within 50-mile radius of hospital
Infant Inclusion Criteria:
- Born less than 35 week gestation
- No congenital anomalies that could interfere with feeding (e.g., diaphragmatic hernia,
cleft lip/palate tracheoesophageal fistula, and cardiac anomalies
Maternal Exclusion Criteria:
- Chronic neuroendocrine or immunologic condition
- Currently using guided imagery or other mind-body techniques such as meditation
- Psychiatric disorder involving a history of dissociative disorders, borderline
personalities, and psychotic pathology
Infant Exclusion Criteria:
- Grade III or IV intraventricular hemorrhage
- Surgical necrotizing enterocolitis
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