Effect of Finger Feeding

Effect of Finger Feeding on Term Newborns: A Randomized Controlled Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Finger Feeding; Alternative Feeding Methods
• Intervention / Treatment: Other: Finger feeding

Detailed Description

It was planned as a randomized controlled experimental study design.

Full randomization will be performed and infants who meet the inclusion criteria will be assigned to groups by flipping a coin.

On the toss of a coin, if heads came up then subject was allocated to the control group. If tails came up, then subject was allocated to the intervention group. This procedure was repeated for each mother.

Within the scope of the study, "Informed consent" will be obtained from the parents for infants who need formula supplementation or for infants fed with expressed breast milk by the decision of the Physician in the experimental and control groups.

Babies in the control group will continue to receive routine care and no intervention will be made on their feeding style. The researcher will be informed verbally and practically about the finger feeding method and the application steps to the mothers of the babies in the experimental group and to the family members who will support their feeding in baby care. In this direction, it will be ensured that expressed breast milk or formula support is given by finger feeding method.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Amasya, Turkey, 05100
    • Amasya University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; It is the group that will receive breast milk or formula by finger feeding.	Other: Finger feeding; The newborn will receive every expressed breast milk or formula support during the day with the finger feeding method.
No Intervention: Control group; No Intervention: control group attempt will not be implemented

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Amasya University
• Collaborators: Mustela Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): October 15, 2023
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Finger Feeding
• Other Study ID Numbers: 106728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It will be shared if requested and deemed appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No