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临床试验/NCT04638127
NCT04638127已完成不适用

PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Maternal Self-Rating of Depression

研究概览

简要总结

The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

详细描述

Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking parents
  • Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA)
  • Parents who had a singleton or twin birth
  • Parents 18 years of age or older

排除标准

  • Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent
  • Infants with imminent or probable death based on the healthcare team's judgement

研究组 & 干预措施

PREEMIE PROGRESS

Experimental

PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

干预措施: PREEMIE PROGRESS (Behavioral)

Attention Control

Active Comparator

To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.

干预措施: Attention Control (Behavioral)

结局指标

主要结局

Maternal Self-Rating of Depression

时间窗: Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.

Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.

Maternal Self-Rating of Anxiety

时间窗: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.

Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.

Receipt of Exclusive Mother's Human Milk

时间窗: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).

Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds

Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age

时间窗: Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.

Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]

NICU Length of Stay

时间窗: Date of NICU discharge will be assessed until study completion, with maximum of 1 year

Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)

Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response

时间窗: Thirty days after infant discharge from the NICU.

The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked "Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?", to ensure all rehospitalizations and ED visits were captured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Weber

Assistant Professor

University of Cincinnati

研究点 (2)

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