Feeding and Sucking in Preterm Infants

Not Applicable

Completed

• Conditions: Breast Feeding; Preterm Birth Complication
• Interventions: Behavioral: oral motor stimulation

• Registration Number: NCT04751903
• Lead Sponsor: Bozok University

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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Study Timeline

• Study Start: 2017-05-05
• Primary Completion: 2017-08-18
• Study Completion: 2018-03-19
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral motor stimulation	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.

Primary Outcome Measures

Name	Time	Method
LATCH Breastfeeding Assessment Tool	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.
body weight	36th gestational week ,3 minute	The baby's body weight is weighed in grams with a digital scale.
head circumference	36th gestational week ,1 minute	The baby's head circumference is measured in cm with a tape measure.
length	36th gestational week,1 minute	The baby's length is measured in cm with a tape measure.

Trial Locations

Locations (1)

Bozoku; 🇹🇷 Yozgat, Turkey