Feeding and Sucking in Preterm Infants
Primary Purpose
Preterm Birth Complication, Breast Feeding
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral motor stimulation
Sponsored by

About this trial
This is an interventional supportive care trial for Preterm Birth Complication focused on measuring Feeding, Sucking success, Oral motor stimulation, Preterm infant
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.
Sites / Locations
- Bozoku
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oral motor stimulation
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
body weight
The baby's body weight is weighed in grams with a digital scale.
length
The baby's length is measured in cm with a tape measure.
head circumference
The baby's head circumference is measured in cm with a tape measure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04751903
Brief Title
Feeding and Sucking in Preterm Infants
Official Title
The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
August 18, 2017 (Actual)
Study Completion Date
March 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozok University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth Complication, Breast Feeding
Keywords
Feeding, Sucking success, Oral motor stimulation, Preterm infant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist
Masking
Participant
Masking Description
The study was conducted at neonatal intensive care unit (NICU) of the university hospital located in eastern Turkey between May 5th, 2017 and March 19th, 2018. The preterm infants were randomly allocated to two groups, experimental group and control group, by a computer-generated number table. The sample consisted of 77 preterm infants (39 in the experimental group and 38 in the control group) who met the inclusion criteria. The gestational weeks when babies are born were grouped as follows: 29-30 weeks, 31-32 weeks, and 33-34 weeks. In this study, only one researcher (1st author) who was not included in the intensive care team administered OMS to all the infants. Thus, the families and the NICU team were double-blinded.
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral motor stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
oral motor stimulation
Intervention Description
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 Outcome Measure Information:
Title
LATCH Breastfeeding Assessment Tool
Description
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.
Time Frame
36th gestational week , 5 minute
Title
body weight
Description
The baby's body weight is weighed in grams with a digital scale.
Time Frame
36th gestational week ,3 minute
Title
length
Description
The baby's length is measured in cm with a tape measure.
Time Frame
36th gestational week,1 minute
Title
head circumference
Description
The baby's head circumference is measured in cm with a tape measure.
Time Frame
36th gestational week ,1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayda ÇELEBİOĞLU, Prof.
Organizational Affiliation
Mersin Univers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof
Organizational Affiliation
Atatürk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bozoku
City
Yozgat
ZIP/Postal Code
66100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
31814522
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.
Results Reference
background
PubMed Identifier
24461572
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.
Results Reference
background
PubMed Identifier
22497742
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.
Results Reference
background
PubMed Identifier
30851536
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.
Results Reference
background
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Feeding and Sucking in Preterm Infants
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