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Effect of PIOMI combined with music therapy on feeding progression of premature infants

Protocol summary

Study aim
To investigate the combined effect of music therapy and PIOMI on the feeding progression of preterm infants of 26 to 30 gestational age
Design
A clinical trial with a control group, parallel, blinded, randomized groups on 58 premature infants
Settings and conduct
The intervention is performed individually, once a day for 10 days. In the intervention group, 5 minutes of PIOMI and 10 minutes of Mozart music are performed daily, and in the control group, only 5 minutes of PIOMI is presented. In the final stage of PIOMI (non-nutritive sucking lasting 2 minutes), Mozart's music is played and continues for another 8 minutes. The music is played by a disinfected speaker inside the incubator at distance of 30 cm from the infants’ ear with a intensity of 45 dB. Before, during, and after the stimulation, the researcher monitors vital signs using a monitor, and if any symptoms of infant intolerance occurs through the number of breath, facial expressions, and gestures, the stimuli stop. Assessments are performed by a nurse.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.gestational age between 26 and 30 weeks at birth 2.physiological stability and lack of stress symptoms with stimulation 3. Apgar score 7 and above in 5 minutes after birth 4. Parental consent 5. Infants without congenital anomalies 6. Infants without any chronic medical problems such as asphyxia or fetal distress at birth, ... 7. Failure to get gavage before the end of the 30th week of gestational age. Exclusion criteria: Parents refuse to continue or transfer to other centers
Intervention groups
In the intervention group, 5 minutes of PIOMI and 10 minutes of Mozart-music and in the control group 5 minutes of PIOMI are presented
Main outcome variables
Gestational age Weight Oral feeding Average weight gain Hospitalization days in the NICU

General information

Reason for update
Acronym
PIOMI
IRCT registration information
IRCT registration number: IRCT20210502051155N1
Registration date: 2021-09-18, 1400/06/27
Registration timing: registered_while_recruiting

Last update: 2021-09-18, 1400/06/27
Update count: 0
Registration date
2021-09-18, 1400/06/27
Registrant information
Name
Elmira Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7644 4705
Email address
e.sh855@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of PIOMI combined with music therapy on feeding progression of premature infants
Public title
Effect of PIOMI combined with music therapy on feeding of premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-menstrual age between 26 and 30 weeks at birth Physiological stability and lack of stress symptoms when presenting stimuli Apgar score 7 and above in 5 minutes after birth Obtaining written consent from parents in order to participate in the research Absence of any congenital anomalies and chronic medical problems such as asphyxia , neonatal seizures, grade 3 and 4 intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, jaundice, and hearing loss. Infants who have started gavage feeding by the end of the 30th week of pregnancy.
Exclusion criteria:
Parental disapproval or transfer to other health center
Age
From 182 days old to 210 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done based on the sequence created by the computer or using the site, the second step is to hide the random allocation, which is done using opaque and sealed envelopes, and Sequences will be recorded on the cards. At the time of registration, the envelopes are opened according to the order of entry of the envelopes and the allocation group is determined. People who are in random allocation and the person who assigns participants will be different.
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention is presented by the researcher and the outcome assessment is performed by a trained nurse using the POFRAS index.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation sciences
Street address
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.USWR.REC.1400.106

Health conditions studied

1

Description of health condition studied
preterm infants
ICD-10 code
P92.9
ICD-10 code description
Feeding problem of newborn, unspecified

Primary outcomes

1

Description
Feeding progression
Timepoint
Before the intervention and day 5 and 10 of the intervention
Method of measurement
Preterm Oral Feeding Readiness Assessment Scale(POFRAS)

Secondary outcomes

1

Description
days of NICU hospitalization
Timepoint
daily
Method of measurement
Counting the days

2

Description
Average weight gain
Timepoint
daily
Method of measurement
scale-gramme

3

Description
weight
Timepoint
daily
Method of measurement
scale-gramme

4

Description
gestational age
Timepoint
daily
Method of measurement
Number of days

Intervention groups

1

Description
Intervention group:5 minutes daily intervention of motor-oral intervention of preterm infants PIOMI and 10 minutes of presentation of Mozart music. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day. In the final stage of PIOMI intervention, non-nutritional sucking (which lasts for 2 minutes), Mozart's music is played and lasts for another 8 minutes, with a final presentation of 10 minutes. The music is played by a disinfected speaker inside the incubator at a distance of 30 cm from the baby's ear with a intensity of 45dB. During interventions, ambient temperature and noise are kept constant, and doors are closed to minimize noise. Before, during, and after the stimulation is presented to the infant, the researcher monitors vital signs using a monitor, and if any symptoms of infant intolerance occur through the number of breaths, facial expressions, and gestures, the stimuli are stopped immediately. Technique: 1.Cheek C stretch:One finger in the cheek and one outside cheek.Slide and stretch tissue front to back toward the ear,& back to front.Move slowly.Do both cheeks twice. 2.Lip roll: Gently roll the lip between your thumb and finger (like rolling a pea).Roll both sides of upper lip once.Roll both sides of lower lip once. 3.Lip curl or lip stretch: Compress lip between thumb and finger,and curl downward.Curl both sides of upper lip once,and both sides of lower lip once.If lip is too small to grip for the curl,do the Lip Stretch:Lay finger across upper lip,gently compress and stretch side to sideRepeat on lower lip. 4.Gum massage: Use finger to put gentle pressure on outside of upper gum.Move finger slowly around upper gum to other side of mouth. (Be sure to touch outer gum surface,not biting surface.)Repeat on lower gum. 5.Lateral border of tongue/cheeks: Put finger beside ongue and push to the middle.Then move finger back into cheek,stretching it.Repeat on the other side of tongue/cheek. 6.Midblade of tongue/palate: Use finger to put pressure on roof of mouth for 3 seconds.Move finger down to tongue and gently press tongue down.Move finger back up to hard palate.Repeat these movements twice. 7.Elicit a suck: Put finger or pacifier on tongue and gently stroke to allow sucking. 8.Support for non nutritive sucking: Allow sucking on finger or pacifier for 2 minutes.
Category
Rehabilitation

2

Description
Control group: 5 minutes of PIOMI intervention is provided. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Elmira Shokri
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Elmira Shokri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7644 4705
Fax
Email
e.sh855@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Elmira Shokri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7644 4705
Fax
Email
e.sh855@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Elmira Shokri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7644 4705
Fax
Email
e.sh855@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document
There is no more information
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