Learning Early Infant Feeding Cues
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Learning Early Infant Feeding Cues.
- Who it may be relevant to
- Registry conditions: Responsive Feeding, Infants, Weight Gain Trajectory. Basic parameters: from 2 Weeks · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads
Overview
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.
Interventions
- 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 assi
Primary outcome measures
- Responsive Feeding [Time frame: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.]
Secondary outcome measures (3)
- Infant growth trajectory [Time frame: Infant age of 2 weeks to 6 months.]
- Age of complementary food introduction [Time frame: weeks or months since birth]
- Duration of any breastfeeding [Time frame: weeks or months since birth]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 36853761
Identifiers
NCT: NCT06127914 · STUDY00004685