Feeding and Sucking in Preterm Infants

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751903
• Other study ID #: 216S081
• Secondary ID: 216S081
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: February 2021
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 19, 2018
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Weeks to 33 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding
• Premature Birth
• Preterm Birth Complication

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bozoku	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Aguilar-Rodríguez M, León-Castro JC, Álvarez-Cerezo M, Aledón-Andújar N, Escrig-Fernández R, Rodríguez de Dios-Benlloch JL, Hervás-Marín D, Vento-Torres M. The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial. Phys Occup Ther Pediatr. 2020;40(4):371-383. doi: 10.1080/01942638.2019.1698688. Epub 2019 Dec 9. — View Citation

Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23. — View Citation

Coker-Bolt P, Jarrard C, Woodard F, Merrill P. The effects of oral motor stimulation on feeding behaviors of infants born with univentricle anatomy. J Pediatr Nurs. 2013 Jan;28(1):64-71. doi: 10.1016/j.pedn.2012.03.024. Epub 2012 Apr 10. — View Citation

Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LATCH Breastfeeding Assessment Tool	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
Primary	body weight	The baby's body weight is weighed in grams with a digital scale.	36th gestational week ,3 minute
Primary	length	The baby's length is measured in cm with a tape measure.	36th gestational week,1 minute
Primary	head circumference	The baby's head circumference is measured in cm with a tape measure.	36th gestational week ,1 minute