NCT05059574

Brief Summary

It has been clearly demonstrated by the literature that the way of initiation of breastfeeding is highly correlated with the success and continuation of breastfeeding and the level of breastfeeding intention. Crawling to the breast is the reflex of seeking the breast by smelling the breastmilk of the newborn as the first form of breastfeeding. Although crawling to the breast is a studied subject in the international literature, it has remained only in the compilation stage in the national literature. The fact that research on breast crawling has not yet been conducted in our country constitutes the original value of this study. This study was planned to examine the effect of crawling to the breast after vaginal delivery compared to biological breastfeeding on breastfeeding success and mothers' attitude to feed their babies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 13, 2021

Last Update Submit

September 20, 2021

Conditions

Keywords

Breast CrawlingVaginal DeliveryBreastfeeding Success

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding success measurement

    Determining the success of breastfeeding by getting a higher score on the LATCH Breastfeeding Diagnostic Scale in the experimental group, in which the first breast-feeding was applied by crawling to the breast compared to the control group.

    2 years

  • Measuring mothers' feeding attitudes of their babies

    In the experimental group in which the first breast-feeding was applied by crawling to the breast, the mothers' milk feeding behavior increased by getting a higher score on the "The Iowa Infant Feeding Attitude Scale" compared to the control group.

    2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Mothers in this group will begin their baby's first breastfeeding by crawling to the breast.

Behavioral: Breast Crawling

Control group

NO INTERVENTION

Mothers in this group will begin their baby's first breastfeeding with biological breastfeeding.

Interventions

Breast CrawlingBEHAVIORAL

The mother's first breast-feeding of her baby is not routine biological breast-feeding, but as a cradle to the breast.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer to participate in the research,
  • Vaginal birth,
  • Over 18 years old,
  • Able to read and write
  • Can speak Turkish,
  • Having a full-term and healthy birth (38-42 weeks old, born 2500-4000gr, born with a 5th minute apgar of 7 and above, no known congenital disease),
  • Does not have a disease that prevents breastfeeding

You may not qualify if:

  • Not voluntarily to participate in the research,
  • Cesarean delivery,
  • Having a health problem in which the mother or baby is at risk,
  • Those who have a disease that prevents breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (3)

  • Hym C, Forma V, Anderson DI, Provasi J, Granjon L, Huet V, Carpe E, Teulier C, Durand K, Schaal B, Barbu-Roth M. Newborn crawling and rooting in response to maternal breast odor. Dev Sci. 2021 May;24(3):e13061. doi: 10.1111/desc.13061. Epub 2020 Dec 5.

    PMID: 33174352BACKGROUND
  • Henderson A. Understanding the breast crawl: implications for nursing practice. Nurs Womens Health. 2011 Aug-Sep;15(4):296-307. doi: 10.1111/j.1751-486X.2011.01650.x. No abstract available.

    PMID: 21884495BACKGROUND
  • Heidarzadeh M, Hakimi S, Habibelahi A, Mohammadi M, Shahrak SP. Comparison of Breast Crawl Between Infants Delivered by Vaginal Delivery and Cesarean Section. Breastfeed Med. 2016 Aug;11(6):305-308. doi: 10.1089/bfm.2015.0168. Epub 2016 May 12.

    PMID: 27171469BACKGROUND

MeSH Terms

Conditions

Breast FeedingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Since there is no placebo group, masking will not be done.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: While crawling to the breast is tried in the experimental group, biological breastfeeding will be applied in the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 28, 2021

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

The follow-up of the study data will be provided by both researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be kept by the researchers until the study is reported. After the study is published, it will contribute to the literature.
Access Criteria
After the study is reported and published, it will be shared.

Locations