Feeding and Sucking in Preterm Infants

NCT ID: NCT04751903

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2018-03-19

Brief Summary

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

Detailed Description

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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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Conditions

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Preterm Birth Complication Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

oral motor stimulation

Intervention Type 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

29 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bozok University

OTHER

Sponsor Role lead

Responsible Party

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Şenay ARAS DOĞAN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayda ÇELEBİOĞLU, Prof.

Role: PRINCIPAL_INVESTIGATOR

Mersin Univers

Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Bozoku

Yozgat, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31814522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24461572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22497742 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30851536 (View on PubMed)

Other Identifiers

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216S081

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

216S081

Identifier Type: -

Identifier Source: org_study_id

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