Breast Versus Bottle Study

February 6, 2024 updated by: Alison Ventura, California Polytechnic State University-San Luis Obispo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2-hour period
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.
2-hour period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological Synchrony
Time Frame: 2-hour period
During each feeding observation, we will also assess both the mothers' and the infant's physiological response (i.e., heart rate variability) to the feeding using electrocardiogram (ECG; BioPac MP160 data acquisition system, BioPac Systems, Inc., Goleta, CA). Two disposable pediatric electrodes will be placed on the infant's chest and one electrode will be placed on the infant's back immediately prior to the start of each feeding. Three disposable electrodes will be placed on the mother's chest immediately prior to the start of each feeding. All electrodes will be wireless and will be placed at least 5 minutes prior to the feeding to allow mothers and infants to become acclimated. Our main variable of interest will be maternal and infant heart rate variability, assessed by estimating inter-beat-intervals (IBI) to determine variation in R-R intervals of the heartbeat during the feeding.
2-hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California Polytechnic State University-San Luis Obispo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison K Ventura, PhD, Cal Poly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-143-CO
  • R03HD096164 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not currently plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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