Clinical trial NCT03664154: Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
Official title: Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Preterm Infant
Stress
Mother-Infant Interaction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A one-group longitudinal repeated measures design. Data will be collected at baseline, 8-weeks, 12-weeks, and 16-weeks
Primary purpose: PREVENTION

Brief summary: 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 on mother and infant outcomes over 16-weeks.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ease of recruitment of participants
timeFrame: 12-months after study opens to enrollment
measure: Track non-participation
timeFrame: 16-weeks after start of intervention
measure: Adherence
timeFrame: 16-weeks after start of intervention
measure: Data collection completeness
timeFrame: 16-weeks after start of intervention
measure: Appraisal of SAFE's degree of inconvenience
timeFrame: 16-weeks after start of intervention
measure: Satisfaction with intervention
timeFrame: 16-weeks after start of intervention
Secondary outcomes:
measure: Change in maternal stress
timeFrame: Baseline to 16-weeks post-baseline
measure: Changes in mother biological stress
timeFrame: Baseline to 16-weeks post-baseline
measure: Changes in infant biological stress
timeFrame: Baseline to 16-weeks post-baseline
measure: Changes in mother-infant feeding behaviors
timeFrame: Baseline to 16-weeks post-baseline
Other outcomes:
measure: Practicability of collecting cortisol
timeFrame: 16-weeks after start of intervention
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lisa F Brown, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pridham K, Brown R, Clark R, Limbo RK, Schroeder M, Henriques J, Bohne E. Effect of guided participation on feeding competencies of mothers and their premature infants. Res Nurs Health. 2005 Jun;28(3):252-67. doi: 10.1002/nur.20073.
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citation: Rogoff, B. (2003). The cultural nature of human development. New York: Oxford University Press.
citation: Schroeder M, Pridham K. Development of relationship competencies through guided participation for mothers of preterm infants. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):358-68. doi: 10.1111/j.1552-6909.2006.00049.x.
citation: Wethington, E., Glanz, K., & Schwartz, M. (2015). Stress, coping and health behavior. In K. Glanz, B. K. Rimer, & K. Viswanath (Eds.), Health Behavior: theory, Research & Practice (5th ed., pp. 223-242). San Francisco, CA: Jossey-Bass.
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