The Effect of Routine and Random Pacifier Use Methods in Preterm Infants

NCT05036915 | Completed

• 1 other identifier: ATADEK-2021/08
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.

Conditions

Feeding; Neonatal

Keywords

Preterm; Non-nutritive sucking; Feeding

Outcome Measures

Primary Outcomes (3)

• Change in feed intake

  Change in feed intake will be assessed from baseline to transition to total oral feeding

  From baseline to transition to total oral feeding (average 15 weeks)

• Change in body weight

  Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion

  From baseline to transition to total oral feeding (average15 weeks)

• Length of hospital stay

  The time from date of hospitalization until the date of discharge.

  From baseline to discharge (average 15 weeks)

Study Arms (2)

Control group (Pacifier randomly 30 min)

EXPERIMENTAL

Pacifier is randomly given to the infant for 30 min independent from feeding during the day

Procedure: Pacifier randomly

Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding)

EXPERIMENTAL

Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.

Procedure: Pacifier other

Interventions

Pacifier randomly PROCEDURE

Common Action Steps: 1. Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained. 2. Inclusion and exclusion criteria are evaluated. 3. Study group is determined in line with the randomization order of the newborn to be included in the study. 4. First part of the patient information and follow-up form is completed. 5. Feeding content, amount and method are determined by the physician. Action Steps of the Control Group: \* Pacifier is randomly given to the infant for 30 min independent from feeding during the day. 1. Common procedure steps are applied. 2. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. 3. Second part of the patient information and follow-up form is completed daily.

Control group (Pacifier randomly 30 min)

Pacifier other PROCEDURE

Procedure Steps of the Experimental Group: * Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding. 1. Common procedure steps are applied. 2. Pacifier is given for 5 min before each feeding. 3. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. 4. Second part of the patient information and follow-up form is completed daily.

Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants;
• Whose legal representatives agree to take part in the study and sign the informed consent form,
• Who have a stable clinical picture,
• Who are on the first day of enteral feeding will be included in the study.

You may not qualify if:

• Preterm infants;
• Who have a comorbidity,
• Who are intubated,
• Who have an inherent anomaly,
• Who have parenteral feeding will not be included in the study.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University Atakent Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Dur S, Gozen D. Nonnutritive Sucking Before Oral Feeding of Preterm Infants in Turkey: A Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e37-e43. doi: 10.1016/j.pedn.2020.12.008. Epub 2021 Jan 6.

  PMID: 33422394 RESULT

• Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.

  PMID: 27699765 RESULT

• Fucile S, Phillips S, Bishop K, Jackson M, Yuzdepski T, Dow K. Identification of a Pivotal Period in the Oral Feeding Progression of Preterm Infants. Am J Perinatol. 2019 Apr;36(5):530-536. doi: 10.1055/s-0038-1669947. Epub 2018 Sep 12.

  PMID: 30208500 RESULT

• Ostadi M, Jokar F, Armanian AM, Namnabati M, Kazemi Y, Poorjavad M. The effects of swallowing exercise and non-nutritive sucking exercise on oral feeding readiness in preterm infants: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2021 Mar;142:110602. doi: 10.1016/j.ijporl.2020.110602. Epub 2020 Dec 29.

  PMID: 33412344 RESULT

• Pineda R, Dewey K, Jacobsen A, Smith J. Non-Nutritive Sucking in the Preterm Infant. Am J Perinatol. 2019 Feb;36(3):268-276. doi: 10.1055/s-0038-1667289. Epub 2018 Aug 6.

  PMID: 30081403 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Zehra Kan Öntürk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: September 8, 2021
• Study Start: May 2, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)