Breastfeeding First, Bottle-feeding Second, PBF Third for Bottle Feeding

California Polytechnic State University, San Luis Obispo, CA
Bottle Feeding+2 More ConditionsPaced Bottle-Feeding Education - Behavioral
Eligibility
< 65
All Sexes

Study 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.

Eligible Conditions
  • Bottle Feeding
  • Breastfeeding
  • Mother-Infant Interaction

Treatment Effectiveness

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: 3 visits across a 1 week period

Week 1
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
Change in Infant Responsiveness to Caregiver between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Maternal Responsiveness to Infant Distress between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Maternal Sensitivity to Infant Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Meal Duration between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
Change in Rate of Feeding between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Breastfeeding First, Bottle-feeding Second, PBF Third
1 of 2
Bottle-feeding First, Breastfeeding Second, PBF Third
1 of 2

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Breastfeeding First, Bottle-feeding Second, PBF Third · No Placebo Group · N/A

Breastfeeding First, Bottle-feeding Second, PBF Third
Behavioral
Experimental Group · 1 Intervention: Paced Bottle-Feeding Education · Intervention Types: Behavioral
Bottle-feeding First, Breastfeeding Second, PBF Third
Behavioral
Experimental Group · 1 Intervention: Paced Bottle-Feeding Education · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 visits across a 1 week period

Who is running the clinical trial?

California Polytechnic State University-San Luis ObispoLead Sponsor
28 Previous Clinical Trials
3,190 Total Patients Enrolled
Alison K Ventura, PhDPrincipal InvestigatorAssociate Professor
6 Previous Clinical Trials
330 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are concurrently nourishing through breastfeeding and bottle-feeding.
The infant has not commenced consuming solid foods.
You are proficient in either English or Spanish.
You are between 18 and 40 years old, if you are the mother.
The participant must be an infant between 0 and 24 weeks of age.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.