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Paced Bottle-Feeding Education for Mother-Infant Interaction (PBF Trial)
N/A
Recruiting
Led By Alison K Ventura, PhD
Research Sponsored by California Polytechnic State University-San Luis Obispo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 visits across a 1 week period
Awards & highlights
PBF Trial Summary
This trial will explore how bottle-feeding can promote healthy eating for infants, as well as how families who bottle-feed can be better supported.
Who is the study for?
This trial is for English or Spanish-speaking mothers aged 18-40 who are currently breastfeeding and bottle-feeding their infants, aged 0-24 weeks. The babies must not have started solid foods yet. Preterm infants born before 37 weeks are excluded.Check my eligibility
What is being tested?
The study tests the Paced Bottle-Feeding (PBF) method against typical bottle-feeding to see if it improves feeding interactions by letting the baby control the pace in response to hunger and fullness, similar to breastfeeding.See study design
What are the potential side effects?
Since this trial involves educational intervention rather than medication, there aren't traditional side effects; however, changes in infant feeding behavior or maternal stress levels could potentially occur.
PBF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 visits across a 1 week period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 visits across a 1 week period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Frequency of Spitting Up During and After the Meal between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Infant Clarity of Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Infant Milk Intake between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
+5 morePBF Trial Design
2Treatment groups
Experimental Treatment
Group I: Breastfeeding First, Bottle-feeding Second, PBF ThirdExperimental Treatment1 Intervention
Mother-infant dyads will visit the laboratory on three different days. During the first visit, they will be observed during breastfeeding. During the second visit, they will be observed during bottle-feeding. During the third visit, the mother will be taught the PBF approach and will be observed using it during bottle-feeding.
Group II: Bottle-feeding First, Breastfeeding Second, PBF ThirdExperimental Treatment1 Intervention
Mother-infant dyads will visit the laboratory on three different days. During the first visit, they will be observed during bottle-feeding. During the second visit, they will be observed during breastfeeding. During the third visit, the mother will be taught the PBF approach and will be observed using it during bottle-feeding.
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Who is running the clinical trial?
California Polytechnic State University-San Luis ObispoLead Sponsor
29 Previous Clinical Trials
3,239 Total Patients Enrolled
Alison K Ventura, PhDPrincipal InvestigatorAssociate Professor
6 Previous Clinical Trials
382 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.I am a mother aged between 18 and 40.My baby is between 0 to 24 weeks old.My infant has not started eating solid foods.
Research Study Groups:
This trial has the following groups:- Group 1: Bottle-feeding First, Breastfeeding Second, PBF Third
- Group 2: Breastfeeding First, Bottle-feeding Second, PBF Third
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining openings for participants in this experiment?
"As per the particulars outlined on clinicaltrials.gov, enrollment for this medical experiment is still ongoing. The posting of the study was dated February 10th 2023 with its last modification taking place a month later."
Answered by AI
How many individuals are enrolled in the current clinical trial?
"Affirmative. The information posted on clinicaltrials.gov affirms the recruitment of participants for this medical experiment, which was first listed on February 10th 2023. As of March 10th 2023, 48 subjects need to be recruited from a single site."
Answered by AI
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