Suction and Swalloing Exercises for Premature Babies

The Effects of Sucking and Swallowing Exercises on the Transition Process to Oral Feeding in Premature İnfants

Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.

This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.

The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.

Study Overview

• Status: Completed
• Conditions: Premature Infant
• Intervention / Treatment: Behavioral: Sucking and swallowing exercises

Detailed Description

This study was conducted as a randomized controlled experimental study to evaluate the effect of sucking and swallowing training on the transition to oral feeding in premature infants. The study sought to answer the question, "Do suckling and swallowing exercises have an effect on the transition to oral feeding?". The study was carried out between December 2021 and June 2022 at the neonatal intensive care unit of a public hospital in Istanbul. The study sample consisted of infants who were admitted to the neonatal intensive care unit of a public hospital in Istanbul, who met the inclusion criteria, and whose parents consented to the study. A power analysis was performed to determine the number of subjects to be included in the study. The power of the test was calculated using the G*Power 3.1 program. Infants enrolled in the study were randomized in order of arrival to avoid bias. The randomization table was generated by "https://www.calculatorsoup.com" as follows.

Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool.

The premature infant data collection form developed by the investigators consists of 2 parts. The first part contains descriptive information about the parents (gender, age, education level, number of children, social security). The second part contains descriptive details of the infant (sex, mode of delivery, Apgar score, week of birth, postmenstrual week at enrollment, birth weight, weight at enrollment, head circumference-height at birth, phototherapy status within the last 24 hours, oxygen support status).

Application in the experimental group: Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria. After completing the premature infant data collection form, the investigator assessed the infant's sucking activity. Infants with no suck reflex were included in the study group. The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool. The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days. After 14 days, the infants were assessed again using the EFS scale.

Application in the control group: First, informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria. After completing the premature infant data collection form, the infant's sucking activity was assessed. Infants who did not show a suck reflex were included in the study group, and the infants were evaluated using the Early Feeding Skills (EFS) measurement tool at baseline and at 14 days.

The data collected in the study were analyzed using SPSS (Statistical Package for Social Sciences) 22.0 for Windows software. Numbers, percentages, means, and standard deviations were used as descriptive statistical methods to analyze the data. Kurtosis and skewness values were examined using chi-square and t-tests to determine whether the study variables were normally distributed.

The study was conducted after obtaining the necessary permissions from XXXXXXXX Non-Interventional Clinical Research Ethics Committee (decision number: 1054, date: 26.10.2021) and the hospital where the study was to be conducted, as well as the informed consent of the parents who consented their children to participate in the study. Infants enrolled in the study were not exposed to practices or procedures that would violate patient rights, that parents would consider inappropriate, or that would adversely affect the patient.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34810
      • Medipol University

Participation Criteria

Eligibility Criteria

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

Study Population

The sample of the study consisted of a total of 82 infants, who were in the neonatal intensive care unit of a public hospital in Istanbul, at 34th to 37th gestational weeks, In the power analysis for the sample size, the power of the study was found to be 0.966 when 41 premature babies were included in the experimental group and 41 premature babies in the control group, at a significance level of 0.05 and a confidence interval of 0.95.

Description

Inclusion criteria

• Premature babies with an updated gestational week of 34 weeks
• Premature babies born at 34-37 weeks of gestation
• Premature babies with stable vital signs
• Premature babies with underdeveloped sucking activity

Exclusion criteria

• intubated babies
• Babies with multiple anomalies
• Babies with asphyxia
• Infants with unstable vital signs

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; 41 premature infants in the experimental group	Behavioral: Sucking and swallowing exercises; Sucking-swallowing exercises were applied to premature infants in the experimental group (n=41) for 14 days, once a day, 12 minutes before feeding.
No Intervention: control group; 41 premature infants in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The early feeding skills assessment tool (EFS)	This scale is a reliable tool that assesses skills that contribute to safe and successful oral feeding of preterm infants in 5 sub-dimensions. Sub-dimensions include respiratory regulation, oral motor function, swallowing coordination, feeding participation, and physiological stability.	December 2021 and June 2022

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Elif Arslan, Medipol University; Study Director: Aysel Kokcu Dogan, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Oral feeding; sucking-swallowing exercises; premature Infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: ayselkokcudogan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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