Learning Early Infant Feeding Cues

Infants Clinical Trial

— LEIFc  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127914
• Other study ID #: STUDY00004685
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: Jessica Bahorski
• Phone: 8506446013
• Email: jbahorski[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks to 34 Years

Eligibility

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 18-34 years

• 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 or greater than 34 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

Related Conditions & MeSH terms

• Infants
• Weight Gain
• Weight Gain Trajectory

Intervention

Behavioral:
• Learning Early Infant Feeding Cues
The LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assist the mother in making decisions regarding feeding her infant. This will begin with milk based feedings (either breastmilk from breast or bottle, or formula from a bottle), and continue through the transition to solid (complementary) foods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responsive Feeding	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.	Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.
Secondary	Infant growth trajectory	Infant weight-for-length z-score (WLz) will be calculated from infant weight and length measurements obtained at each study visit. The difference in WLz between infant age of 2 weeks and 6 months will be calculated. Infants will be categorized into 3 growth categories: expected growth (WLz SD change between -0.67 and 0.67, rapid growth > or equal to 0.67, or slow growth < or equal to -0.67.	Infant age of 2 weeks to 6 months.
Secondary	Age of complementary food introduction	Current infant feeding practices are collected at each study visit. The infant age (in weeks) at which any foods other than breastmilk or formula were given will be tabulated into a variable.	weeks or months since birth
Secondary	Duration of any breastfeeding	Current infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.	weeks or months since birth