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Studying the effect of speech therapy on the growth of premature infants

Protocol summary

Study aim
Investigating the effect of speech therapy on the growth of premature babies in Kotsar Qazvin Hospital
Design
A clinical trial with a control group, with parallel groups, double-blind, Restricted randomization (Permuted block randomization), 70 patients are treated. The evaluator does not know about the treated patients.
Settings and conduct
Patients admitted to Kausar Hospital who are less than 34 weeks pregnant are examined. After examination and having the items to be included in the study, they are selected and entered into the study in a double-blind manner. After entering the study, the speech therapist records the infant's height, weight, and head circumference in the first session. All the variables are checked after 10 speech therapy sessions in the intervention group and the control group, and after the completion of the speech therapy stages, the height, weight and head circumference of the baby are checked again. The evaluator only checks the data and does not know which patient underwent speech therapy.
Participants/Inclusion and exclusion criteria
Entry conditions:All premature babies weighing less than 2 kg; Gestational age less than 34 weeks. Non-entry conditions: Existence of underlying disease.
Intervention groups
The main intervention is speech therapy in premature babies. Babies are divided into two groups of 35 people. The case group is subjected by the therapist to a series of finger maneuvers on the tissues of the face and pharynx, which are responsible for sucking, swallowing and oral reflexes of the baby. In the control group, there is no intervention and all infants participating in the two groups of each session are evaluated in terms of weight growth, height, head circumference, number of sucking, reflux rooting, and the ratio of sucking to biting reflex.
Main outcome variables
Rooting-socking; Baitning; Height; Weight; Around the head; Number of socks

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230213057408N1
Registration date: 2024-07-16, 1403/04/26
Registration timing: prospective

Last update: 2024-07-16, 1403/04/26
Update count: 0
Registration date
2024-07-16, 1403/04/26
Registrant information
Name
sayyedeh Marziyeh mir masoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3345 4576
Email address
mhemati1726@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of speech therapy on the growth of premature infants
Public title
Investigating the effect of speech therapy on the growth of premature infants
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All premature babies weighing less than 2 kg gestational age less than 34 weeks Parents' satisfaction Normal Apgar Only premature infants Failure to receive gavage
Exclusion criteria:
Existence of underlying disease Existence of genetic problems
Age
From 1 day old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two intervention and control groups (A and B) using block randomization method. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks. In this way, we continue until reaching the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
People are coded without name and checked by the evaluator. And the patients do not know whether they are undergoing treatment or not
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Ghazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2022-10-15, 1401/07/23
Ethics committee reference number
IR.QUMS.REC.1401.195

Health conditions studied

1

Description of health condition studied
Growth of premature infants
ICD-10 code
K07.5
ICD-10 code description
Abnormal swallowingmouth breathingtongue, lip or finger habits

Primary outcomes

1

Description
Height
Timepoint
Every week
Method of measurement
Meter

2

Description
Weight
Timepoint
Every week
Method of measurement
Scale

3

Description
A round of head
Timepoint
Every week
Method of measurement
Meter

4

Description
Sucking
Timepoint
Every week
Method of measurement
Counting by the therapist

5

Description
Rooting reflux
Timepoint
Every week
Method of measurement
Intervention and observation by the therapist

6

Description
Ratio of sucking to biting reflex
Timepoint
Every week
Method of measurement
Intervention by the therapist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 35 premature babies undergo treatment sessions for 10 weeks, once a week (maximum 30 minutes). According to the intervention protocol for oral motor therapy of premature infants (PIOMI), a series of pinky maneuvers are performed with the therapist's fingers on the baby's pinky and pharyngeal tissues (effective on sucking, swallowing, and oral reflexes), and there are no tools. After each session, the therapist examines the process of weight growth, baby's height growth, baby's head circumference growth, the number of sucking and rooting reflux, and the predominance of sucking reflex over biting reflex.
Category
Other

2

Description
Control group: 35 premature babies undergo treatment sessions for 10 weeks, once a week (maximum 30 minutes). In this group, the therapist examines the process of weight growth, height growth of the baby, growth of the baby's head, the number of sucking and rooting reflux, and the predominance of the sucking reflex over the biting reflex.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Qazvin educational and therapeutic center
Full name of responsible person
Seyed Hoshiar Mojabi
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
itkosar@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Abdul Razaghi Branch, Mavedat Alley, Tohid St., Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Maleki
Position
University professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
mr.maleki@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Maliki
Position
University professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
mr.maleki@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Marziyeh Mirmasoumi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 36-Unit 1,Farvardin Alley, Aref Square, Padgan Street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3345 4576
Fax
Email
mhemati1726@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The design is still in the data analysis stage and no article has been published yet.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The effect of speech therapy on the growth of premature babies
When the data will become available and for how long
After its publication in scientific articles
To whom data/document is available
Students and professors of the Ministry of Health and Medical Education
Under which criteria data/document could be used
After review and preparation, it can be used for purposeful review and research.
From where data/document is obtainable
To receive information, please refer to Dr. Seyedah Marzieh MirMasoumi. The communication methods are as follows: by sending an email to the e-mail address: mhemati1726@gmail.com or visiting and calling to Kosar Hospital at the address: Taleghani Street, Qazvin. Phone: 028-33236374 Postal address: 13176-34156
What processes are involved for a request to access data/document
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email.
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