Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2024-09-30

Brief Summary

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This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.

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Detailed Description

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Conditions

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Premature Birth of Newborn Intervention Studies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.

Study Groups

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Control

Two 15-minute sessions of sham intervention/day, five days a week

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

DST group

One session of DST and the other of sham intervention/day, five days a week

Group Type EXPERIMENTAL

Direct swallowing training (DST)

Intervention Type OTHER

The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Sham intervention

Intervention Type OTHER

The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

DST+OSMS group

One session of DST and the other of OSMS/day, five days a week

Group Type EXPERIMENTAL

Direct swallowing training (DST)

Intervention Type OTHER

The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Oral sensorimotor stimulation (OSMS)

Intervention Type OTHER

The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Interventions

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Direct swallowing training (DST)

The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Intervention Type OTHER

Oral sensorimotor stimulation (OSMS)

The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Intervention Type OTHER

Sham intervention

The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm infants : before 32+0 weeks gestation
* Infants who are receiving full tube feeding (more than 120 ml/kg/day)
* Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks
* 'Feeders and growers'
* The parents of the subject voluntarily sign the informed consent

Exclusion Criteria

* Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
* Gastrointestinal complications
* Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

31 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No