Feeding and Sucking in Preterm Infants

February 10, 2021 updated by: Şenay ARAS DOĞAN, Bozok University

The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants

This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, with advances in methods of neonatal resuscitation and caring methods, the survival rate of preterm infants has gradually increased. Sucking, swallow and respiratory dysfunction are widespread complications in the preterm infants that reason oral feeding difficulties. Safe and successful oral feeding requires proper maturation of sucking, swallowing, and respiration. The development of behaviors necessary for safe and successful nutrition begins long before birth. Jaw movements begin to be seen in the intrauterine 11th week. But sucking-swallowing-respiratory coordination is not sufficiently developed before 34 weeks of gestation. For this reason, preterm babies at the greater gestational week usually show more developed and consistent feeding skills. Maternal breast milk is best for neurodevelopment in preterm infants. Achieve oral feeding and maternal breast milk as early as possible is beneficial for preterm infants.

Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. Previous studies have indicated that the use of OMS during or before the transition to oral feeding may not only have positive effects on the preterm infants' feeding behaviors but also enhance their general clinical course. Preterm infants who suffer from oral feeding problems often experience longterm health problems and delayed discharge from the hospital. A more effective feeding decreases adverse outcomes by decreasing hospital stays.

Preterm infants are required to prolonged NICU stay in order to stabilized, feeding, and gain optimal weight. Increasing prematurity and reduced birth weight lead to extensive resource utilization. In addition all nutritional options except breast milk increase the cost. OMS can develop sucking success and provide early oral feeding. Thus nurse labor and hospital costs may decrease and OMS can be a cost-effective application.

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Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Yozgat, Turkey, 66100
        • Bozoku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
  • Percentile measurements consistent with their gestational week measurements,
  • Stable vital signs,
  • APGAR scores between 4 and 10 in the 1st and 5th minutes,
  • Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
  • Being breastfed,
  • Mother's eagerness to breastfeed the infant,
  • Voluntary participation of parents in the study.

Exclusion Criteria:

  • Suffered from severe asphyxia,
  • Born with a low birth weight according to gestational week,
  • Have intraventricular bleeding,
  • With a congenital anomaly,
  • Babies without their mother.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral motor stimulation
After the infants were assessed by a neonatologist, Oral motor stimulation was administered to the experimental group thrice a day (at 9:00, 12:00, 15:00 hours) for 15 minutes right before feeding, over a 14-day period.
Behavioral: oral motor stimulation
Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions.It took 15 minutes to apply the OMS by lightly touching their cheeks, lips, gums, and tongue with fingertips for the first 12 minutes, followed by letting the infant suck on a pacifier for the remaining 3 minutes. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants.
No Intervention: Control group
The preterm infant' the control group were only fed by the researcher thrice a day (at 9:00, 12:00, 15:00 hours) over a 14-day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LATCH Breastfeeding Assessment Tool
Time Frame: 36th gestational week , 5 minute
It was developed by Jensen, Wallace, & Kelsay (1994). Demirhan (1997) conducted its Turkey validity test and revealed that it is a reliable and easy-to-use scale. Each criterion is rated in the point range of 0-2 points. Breastfeeding is then assessed based on the sum of these scores. The highest and lowest scores of the tool are 10 and 0, respectively, and higher scores signify breastfeeding/sucking success.
36th gestational week , 5 minute
body weight
Time Frame: 36th gestational week ,3 minute
The baby's body weight is weighed in grams with a digital scale.
36th gestational week ,3 minute
length
Time Frame: 36th gestational week,1 minute
The baby's length is measured in cm with a tape measure.
36th gestational week,1 minute
head circumference
Time Frame: 36th gestational week ,1 minute
The baby's head circumference is measured in cm with a tape measure.
36th gestational week ,1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Investigators

  • Principal Investigator: Ayda ÇELEBİOĞLU, Prof., Mersin Univers
  • Principal Investigator: Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216S081 (Other Grant/Funding Number: The Scientific and Technological Research Council of Turkey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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