NCT06204263

Brief Summary

This study aimed to determine the effect of the finger feeding method applied by fathers on the transition time to oral feeding and sucking success in premature 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
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

5 days

First QC Date

January 3, 2024

Last Update Submit

January 11, 2024

Conditions

Keywords

PrematureFingerFatherFeeding

Outcome Measures

Primary Outcomes (1)

  • Patient Identification Form

    This form contains information such as the age of the mother and father, the baby's weight, time to independent oral feeding, discharge weight, length of hospital stay, fetal age at birth, Apgar score, gender of the baby, etc.

    Baseline

Secondary Outcomes (1)

  • Preterm Baby Monitoring Form

    Baseline

Other Outcomes (1)

  • LATCH Breastfeeding Diagnostic Measurement Tool

    Baseline

Study Arms (2)

Control Group

NO INTERVENTION

Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger).

Experimental Group

EXPERIMENTAL

The baby will be allowed to suck his father's finger for five minutes three times a day before nasogastric feeding.

Other: finger feeding

Interventions

The fathers of premature babies in intensive care will be interviewed and an educational booklet will be prepared about finger feeding, cleaning, hygiene, hand washing, the importance of sucking, and the rules to be followed to prevent infection in the newborn, and how to apply it will be explained by the researcher. Babies will be breastfed three times a day for seven days.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • Premature babies at 29-31 weeks
  • Birth weight of 1300 g or more
  • Those whose 1st and 5th minute Apgar scores are over 6
  • Those whose vital signs and health status are stable
  • In babies who have received mechanical ventilation and continuous positive air pressure support, those who have passed 48 hours after stability has been achieved
  • No facial or oral anomalies
  • Premature babies without swallowing difficulties
  • Those fed via nasogastric tube
  • Fathers who can read, write and speak Turkish
  • Fathers of preterm babies who agreed to participate in the research.

You may not qualify if:

  • Those whose vital and health conditions are unstable
  • Those whose father has a skin condition or those who developed it later
  • Any upper respiratory tract infection in the father
  • Premature babies without swallowing difficulties
  • Fathers who cannot read, write or speak Turkish
  • Fathers with preterm babies who do not consent to this study will not be included in the scope of the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zülbiye DEMİR BARBAK

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • Buldur E, Yalcin Baltaci N, Terek D, Yalaz M, Altun Koroglu O, Akisu M, Kultursay N. Comparison of the Finger Feeding Method Versus Syringe Feeding Method in Supporting Sucking Skills of Preterm Babies. Breastfeed Med. 2020 Nov;15(11):703-708. doi: 10.1089/bfm.2020.0043. Epub 2020 Sep 11.

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • HASAN KAHVECİ

    zulbiye.demir@atauni.edu.tr

    STUDY CHAIR

Central Study Contacts

Zülbiye DEMİR BARBAK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

February 15, 2024

Primary Completion

February 20, 2024

Study Completion

August 20, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations