Learning Early Infant Feeding Cues (NCT06127914) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Learning Early Infant Feeding Cues
39 participantsStarted 2027-07-01
Plain-language 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.
Who can participate
Age range
2 Weeks
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Responsive Feeding
Timeframe: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.