Clinical trial NCT04751903: Feeding and Sucking in Preterm Infants
Official title: The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth Complication
Breast Feeding
Keywords: Feeding
Sucking success
Oral motor stimulation
Preterm infant
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 77
Sex: ALL
Minimum age (years): 29
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist
Primary purpose: SUPPORTIVE_CARE

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

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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Eligibility criteria: 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.

Primary outcomes:
measure: LATCH Breastfeeding Assessment Tool
timeFrame: 36th gestational week , 5 minute
measure: body weight
timeFrame: 36th gestational week ,3 minute
measure: length
timeFrame: 36th gestational week,1 minute
measure: head circumference
timeFrame: 36th gestational week ,1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Bozoku
Study officials:
affiliation: Mersin Univers
name: Ayda ÇELEBİOĞLU, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguilar-Rodriguez M, Leon-Castro JC, Alvarez-Cerezo M, Aledon-Andujar N, Escrig-Fernandez R, Rodriguez de Dios-Benlloch JL, Hervas-Marin 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.
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.
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.
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.