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

Primary Purpose

Feeding, Neonatal

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pacifier randomly
Pacifier other
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Feeding focused on measuring Preterm, Non-nutritive sucking, Feeding

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Acıbadem University Atakent HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group (Pacifier randomly 30 min)

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in feed intake
Change in feed intake will be assessed from baseline to transition to total oral feeding
Change in body weight
Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion
Length of hospital stay
The time from date of hospitalization until the date of discharge.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
March 23, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05036915
Brief Title
The Effect of Routine and Random Pacifier Use Methods in Preterm Infants
Official Title
The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter. Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time. In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding, Neonatal
Keywords
Preterm, Non-nutritive sucking, Feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (Pacifier randomly 30 min)
Arm Type
Experimental
Arm Description
Pacifier is randomly given to the infant for 30 min independent from feeding during the day
Arm Title
Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pacifier randomly
Intervention Description
Common Action Steps: Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained. Inclusion and exclusion criteria are evaluated. Study group is determined in line with the randomization order of the newborn to be included in the study. First part of the patient information and follow-up form is completed. 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. Common procedure steps are applied. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. Second part of the patient information and follow-up form is completed daily.
Intervention Type
Procedure
Intervention Name(s)
Pacifier other
Intervention Description
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. Common procedure steps are applied. Pacifier is given for 5 min before each feeding. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method. Second part of the patient information and follow-up form is completed daily.
Primary Outcome Measure Information:
Title
Change in feed intake
Description
Change in feed intake will be assessed from baseline to transition to total oral feeding
Time Frame
From baseline to transition to total oral feeding (average 15 weeks)
Title
Change in body weight
Description
Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion
Time Frame
From baseline to transition to total oral feeding (average15 weeks)
Title
Length of hospital stay
Description
The time from date of hospitalization until the date of discharge.
Time Frame
From baseline to discharge (average 15 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra Kan Öntürk, Assist Prof
Phone
02165004163
Email
zehrakan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ukke Karabacak, Prof.
Phone
02165004160
Email
ukke.karabacak@acibadem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof
Organizational Affiliation
Acibadem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem University Atakent Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33422394
Citation
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.
Results Reference
result
PubMed Identifier
27699765
Citation
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.
Results Reference
result
PubMed Identifier
30208500
Citation
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.
Results Reference
result
PubMed Identifier
33412344
Citation
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.
Results Reference
result
PubMed Identifier
30081403
Citation
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.
Results Reference
result

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

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