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临床试验/NCT06127914
NCT06127914尚未招募不适用

A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads

Florida State University0 个研究点目标入组 39 人开始时间: 2027年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
39
主要终点
Responsive Feeding

研究概览

简要总结

The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are:

  • What are the contributors and barriers to use of responsive infant feeding?
  • How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy.
  • Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs?

Participants will be asked to:

  • Participate in focus groups to talk about their experiences feeding their baby.

  • Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include:

  • Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach.

  • Agreeing to be video recording during the session when the baby is eating.

  • Completing surveys online.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Weeks 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal Inclusion Criteria
  • Pregnant mother in the 3rd trimester (28 weeks or beyond)
  • Enrolled in a government-funded maternal-child home visiting program
  • Maternal age 18 years or older
  • English or Spanish speaking
  • Anticipated to have custody of infant after birth
  • Healthy pregnancy, no complications that are anticipated to result in a preterm birth or extended hospital stay for mother or infant

排除标准

  • Gave birth to multiple fetuses
  • Age less than 18 years
  • Not fluent in English or Spanish
  • Expected to not have custody of the infant after birth
  • Infant inclusion criteria
  • Born as a singleton (not a twin, triplet, etc.) to a mother enrolled in a maternal-child home visiting program
  • Born full term (37 weeks or beyond)
  • Infant exclusion criteria
  • Congenital anomaly that may interfere with infant feeding or growth after birth (i.e., Down Syndrome, cleft lip/palate)
  • Born preterm (born prior to 37 weeks)
  • NICU stay beyond 48 hours
  • Infant diagnosis of failure to thrive
  • Supplemental oxygen
  • Enteral feeding device used for feedings

研究组 & 干预措施

LEIFc Intervention

Experimental

There is only 1 arm of this study. All participants will receive the LEIFc intervention.

干预措施: Learning Early Infant Feeding Cues (Behavioral)

结局指标

主要结局

Responsive Feeding

时间窗: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.

Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected. Participants will complete the Infant Feeding Questionnaire to provide a subjective measure of responsive feeding. A feeding session will be video recording then coded for instances of infant cues and maternal response to cues to provide an objective measure of responsive feeding.

次要结局

  • Infant growth trajectory(Infant age of 2 weeks to 6 months.)
  • Age of complementary food introduction(weeks or months since birth)
  • Duration of any breastfeeding(weeks or months since birth)

研究者

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

Jessica Bahorski

Assistant Professor

Florida State University

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