Clinical trial NCT05036915: 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
Overall status: COMPLETED
Phase: NA
Conditions: Feeding
Neonatal
Keywords: Preterm
Non-nutritive sucking
Feeding
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in feed intake
timeFrame: From baseline to transition to total oral feeding (average 15 weeks)
measure: Change in body weight
timeFrame: From baseline to transition to total oral feeding (average15 weeks)
measure: Length of hospital stay
timeFrame: From baseline to discharge (average 15 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.