BreastfeedingNCT03704051

Breast Versus Bottle Study

An observational study of Breastfeeding and Bottle Feeding, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions. Read more about this study

Who is it for?: Ages 0 weeks to 40 yearsHealthy volunteers can take part
Conditions the study is for: Breastfeeding, Bottle Feeding
What is being tested?: Mode of Feeding (breastfeeding versus bottle-feeding)
Type of treatment: Lifestyle or therapy programme
How many people: 94 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2018to 1 Jul 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 weeks to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.

Who may be able to join

Mothers 18-40 years of age
Infants 0-24 weeks of age
Infants who have not yet been introduced to complementary foods and beverages
Dyads are breast- and bottle-feeding
Mother is predominantly or solely responsible for infant feeding

Who cannot join

preterm birth (i.e., gestational age <37 weeks)
low birth weight (<2500 g)
maternal smoking during pregnancy
current or past medical conditions that interfere with oral feeding
history of slow growth or failure to thrive
weight for length percentile <5th
diagnosed developmental delay (e.g., Down's syndrome)

Trial locations and contacts

1 site in 1 country.

United States1 site

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion
San Luis Obispo, California, 93401

Other trials in United States

About this study

Conditions: Breastfeeding, Bottle Feeding
Being tested: Mode of Feeding (breastfeeding versus bottle-feeding)
Keywords: infant feeding, feeding interactions, maternal feeding practices, breastfeeding, bottle-feeding
Medical subject headings: Breast Feeding, Bottle Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mode of Feeding (breastfeeding versus bottle-feeding)Behavioural
Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.

Study groups in NCT03704051
Study group	Role	What they receive
Breastfeeding First, then Bottle-feeding		Mother-infant dyads were observed while breastfeeding during their first visit to our laboratory and were observed while bottle-feeding expressed breast milk during their second visit to our laboratory. Receives: Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)
Bottle-feeding First, then Breastfeeding		Mother-infant dyads were observed while bottle-feeding expressed breast milk during their first visit to our laboratory and were observed while breastfeeding during their second visit to our laboratory. Receives: Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)

What is being measured

The primary outcome is the main question the study is designed to answer.

Infant Intake During the Observed Feeding (mL)
For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.
Measured: 2-hour period
Maternal Sensitivity to Infant Cues
Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.
Measured: 2-hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 20181 Jul 2021

First posted12 Oct 2018
Study start15 Oct 2018
Primary completion15 Mar 2020
Study completion1 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BreastfeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case crossover
Time perspective: Cross-sectional
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03704051
Sponsor's protocol ID: 2018-143-CO
Other IDs: R03HD096164
Status last verified: Feb 2024
First submitted: 8 Oct 2018
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We do not currently plan to make individual participant data available to other researchers.

Publications

Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3.
PubMed 33939269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Breast Versus Bottle Study
ClinicalTrials.gov ID: NCT03704051
Acronym / sponsor ID: 2018-143-CO
Conditions: Breastfeeding, Bottle Feeding
Keywords: infant feeding, feeding interactions, maternal feeding practices, breastfeeding, bottle-feeding
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: California Polytechnic State University-San Luis ObispoUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 15 Oct 2018 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 1 Jul 2021 (actual)
First posted: 12 Oct 2018 (actual)
Results: Posted 15 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case crossover
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Breastfeeding First, then Bottle-feeding	–	Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)Mother-infant dyads were observed while breastfeeding during their first visit to our laboratory and were observed while bottle-feeding expressed breast milk during their second visit to our laboratory.
Bottle-feeding First, then Breastfeeding	–	Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)Mother-infant dyads were observed while bottle-feeding expressed breast milk during their first visit to our laboratory and were observed while breastfeeding during their second visit to our laboratory.

Who may qualify

Ages: 0 weeks to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.

Key inclusion criteria (5 listed)

Mothers 18-40 years of age
Infants 0-24 weeks of age
Infants who have not yet been introduced to complementary foods and beverages
Dyads are breast- and bottle-feeding
Mother is predominantly or solely responsible for infant feeding

Key exclusion criteria (7 listed)

preterm birth (i.e., gestational age <37 weeks)
low birth weight (<2500 g)
maternal smoking during pregnancy
current or past medical conditions that interfere with oral feeding
history of slow growth or failure to thrive

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mode of Feeding (breastfeeding versus bottle-feeding)Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.	Behavioural	Bottle-feeding First, then Breastfeeding, Breastfeeding First, then Bottle-feeding

Primary outcome

Infant Intake During the Observed Feeding (mL)
Time frame: 2-hour period
For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.
Maternal Sensitivity to Infant Cues
Time frame: 2-hour period
Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.

Results and safety

Results posted to the registry on 15 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Breastfeeding First, Then Bottle-feeding	48	44
Bottle-Feeding First, Then Breastfeeding	46	46

Primary outcome: Infant Intake During the Observed Feeding (mL)

Time frame: 2-hour period. Mean (Standard Error). Unit: mL

Measure	Breast- Versus Bottle-feeding n = 94
Breastfeeding Condition	91.9 (5.0)
Bottle-feeding Condition	87.6 (5.2)

Breast- Versus Bottle-feeding: p = 0.634, Mixed Models Analysis

Primary outcome: Maternal Sensitivity to Infant Cues

Time frame: 2-hour period. Mean (Standard Error). Unit: units on a scale

Measure	Breast- Versus Bottle-feeding Conditions n = 94
Breastfeeding Condition	14.7 (0.2)
Bottle-feeding Condition	14.3 (0.2)

Breast- Versus Bottle-feeding Conditions: p = 0.115, Mixed Models Analysis

Adverse events

Time frame: For the duration of each participant's participation in the study: ~1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Breastfeeding Condition - Mothers	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Breastfeeding Condition - Infants	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Bottle-feeding Condition - Mothers	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Bottle-feeding Condition - Infants	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Limitations and caveats (from the sponsor): This study consisted of mothers who were exclusively or predominantly breastfeeding and who fed expressed breast milk (not formula) when bottle-feeding.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33939269Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3.
Individual participant dataSharing planned: No. We do not currently plan to make individual participant data available to other researchers.

Related trials for Breastfeeding

Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
RecruitingObservational study
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Pregnancy Related
RecruitingObservational study
Experiences of Mothers Considering Breastfeeding Cessation: Decision-Making, Method Exploration, and Support Needs
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison K Ventura, PhD principal investigator

Cal Poly

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breastfeeding and Bottle Feeding, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Intake During the Observed Feeding (mL) (time frame: 2-hour period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03704051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.