NCT05916079

Brief Summary

The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life. Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied. The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3.3 years

First QC Date

June 13, 2023

Last Update Submit

June 12, 2026

Conditions

Keywords

Breastfeedingsmartphonescreendistractiondevelopmental care

Outcome Measures

Primary Outcomes (4)

  • Variation of Breastfeeding status in both groups

    At 2 months after birth, mothers will be contacted to record their breastfeeding status.

    at 2 months

  • Variation of Breastfeeding status in both groups

    At 3 months after birth, mothers will be contacted to record their breastfeeding status.

    at 3 months

  • Variation of Breastfeeding status in both groups

    At 4 months after birth, mothers will be contacted to record their breastfeeding status.

    at 4 months

  • Variation of Breastfeeding status in both groups

    At 6 months after birth, mothers will be contacted to record their breastfeeding status.

    at 6 months

Study Arms (2)

breastfeeding success (Yes)

Mothers are to be contacted at 1 month to assess the main outcome: breastfeeding status (Yes vs No) classified as breastfeeding success (Yes) or breastfeeding failure (No).

breastfeeding failure (No)

Mothers are to be contacted at 1 month to assess the main outcome: breastfeeding status (Yes vs No) classified as breastfeeding success (Yes) or breastfeeding failure (No).

Eligibility Criteria

Age18 Months+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreastfeeding mothers of Newborn infant
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital

You may qualify if:

  • breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital

You may not qualify if:

  • Mother refusing to participate in the study; hospitalization during the neonatal period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 23, 2023

Study Start

February 16, 2023

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations