NCT05928715

Brief Summary

With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term 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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

March 30, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 3, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 30, 2023

Last Update Submit

June 22, 2023

Conditions

Finger FeedingAlternative Feeding Methods

Keywords

Finger Feeding

Outcome Measures

Primary Outcomes (4)

  • Breastfeeding

    Number of breastfeeding per day

    15 days after the start of the intervention

  • Expressed breast milk

    amount of daily expressed breast milk intake

    15 days after the start of the intervention

  • Formula intake

    amount of daily formula consumption

    15 days after the start of the intervention

  • finger feeding

    number of finger feeding per day

    15 days after the start of the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

It is the group that will receive breast milk or formula by finger feeding.

Other: Finger feeding

Control group

NO INTERVENTION

No Intervention: control group attempt will not be implemented

Interventions

Finger feedingOTHER

The newborn will receive every expressed breast milk or formula support during the day with the finger feeding method.

Experimental group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mother is 18 years or older Newborns 38 weeks and older Newborns who do not have any postnatal health problems and are followed up with the mother Babies taking formula supplements Babies who have difficulty breastfeeding There is no obstacle to breastfeeding or breastfeeding

You may not qualify if:

  • Babies with sucking and swallowing dysfunction Babies with respiratory distress (respiratory rate over 60/min, babies with groaning, nasal wing breathing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Faculty of Health Sciences

Amasya, 05100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

July 3, 2023

Study Start

April 15, 2023

Primary Completion

October 15, 2023

Study Completion

June 15, 2024

Last Updated

July 3, 2023

Record last verified: 2023-03

Locations

TU(1)