Clinical trial NCT06127914: Learning Early Infant Feeding Cues
Official title: A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Responsive Feeding
Infants
Weight Gain Trajectory
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 39
Sex: FEMALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Maternal Exclusion Criteria

* 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

Primary outcomes:
measure: Responsive Feeding
timeFrame: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.
Secondary outcomes:
measure: Infant growth trajectory
timeFrame: Infant age of 2 weeks to 6 months.
measure: Age of complementary food introduction
timeFrame: weeks or months since birth
measure: Duration of any breastfeeding
timeFrame: weeks or months since birth
Other outcomes:
Locations:
Study officials:
References:
citation: Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.