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Completed

NCT Number: NCT04751903

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.

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Key information

Age range

29 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bozoku

Yozgat, 66100, Turkey (Türkiye)

About this study

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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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral motor stimulation

Behavioral

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.

Primary outcomes

  1. 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.

  2. body weight

    Time frame: 36th gestational week ,3 minute

    The baby's body weight is weighed in grams with a digital scale.

  3. length

    Time frame: 36th gestational week,1 minute

    The baby's length is measured in cm with a tape measure.

  4. head circumference

    Time frame: 36th gestational week ,1 minute

    The baby's head circumference is measured in cm with a tape measure.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 12, 2021
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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