determination of effect of Cue-Based Feeding in attainment of full oral feeding in premature infants
Design
Cue-Based Feeding
Settings and conduct
This study is a non-randomized clinical trial. premature neonates 26-32 weeks of embryonic admission in the neonatal intensive care unit at Mashhad Hospital in om al-Binin (Mashhad, Iran).
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Preterm infants are 26-32 PMA
Total intestinal feeding volume and completion of intravenous feeding period
Infants Needing for gavage feeding
Exit criteria:
Premature infants requiring respiratory protection by invasive or non-invasive mechanical ventilation
Infants with IVH Grade 3 and 4
• Infants with abnormalities require surgery
• Babies who are discharged before they have full oral nutrition or are transferred to another hospital
• Infants with sepsis
• Newborns of alcoholic and addicted mothers
• Infants who are taking sleepy or sedative medications such as phenobarbital, midazolam, fentanyl or morphine.
• Infants who lose weight or lose weight after the start of the study for 3 consecutive days
Intervention groups
Cue-Based Feeding
Main outcome variables
time of full oral feeding in premature infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161101030633N3
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3825 8185
Email address
tataris1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cue-Based Feeding in attainment of full oral feeding in premature infants
Public title
The effect of Cue-Based Feeding in attainment of full oral feeding in premature infants
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
PRETERM INFANT 26-32w
Total intestinal feeding volume and completion of intravenous feeding period
Need feeding by gavage method
Exclusion criteria:
intubation or ncpap
IVH 3-4
Need surgery
sepsis
opiom
Taking hypnotic or sedative medications
Weight loss or weight loss for 3 days
Discharge or transfer to another hospital
Neonatal abnormalities require surgery
Age
From 6 months old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
control group=30 Intervention group=30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
... .
Placebo
Not used
Assignment
Other
Other design features
This study is the only study that has been conducted in Iran regarding cue based feeding on neonates' and specially performed in immature newborns of 26-32 week, similar studies performed abroad were premature infants 26-36 week has been reviewed. Since nutritional behavior and development in newborns are completely different before and after 32 weeks, our study has considered this difference and immature newborns have been considered for behavioral and nutritional evolution.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی یزد
Street address
ba honar
City
yazd
Province
Razavi Khorasan
Postal code
0000000000
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
185127/1/17/پ
Health conditions studied
1
Description of health condition studied
preterm
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Achieving full oral nutrition
Timepoint
Time to stop iv- therapy until Exit time of the catheter
Method of measurement
Weighing and Achieving Evolutionary Skills and Discharge
Secondary outcomes
1
Description
Weighin
Timepoint
daily
Method of measurement
Basque Scale (seca)
Intervention groups
1
Description
Intervention group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
om-al-banin Hospital in Mashhad-NICU
Full name of responsible person
HEIDARZADE MOHAMMAD
Street address
ayatollah bahjat st
City
MASHAD
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3607 8748
Email
tataris1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr mohammad por
Street address
safaie st
City
yazd
Province
Yazd
Postal code
0000000000
Phone
+98 35 3824 9706
Email
salimi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
90
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
Yazd University of Medical Sciences
Full name of responsible person
tahere salimi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
safaeie st
City
yazd
Province
Yazd
Postal code
0000000000
Phone
+98 35 3824 1751
Email
salimi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammad heidarzade
Position
Associate professor-Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
bahjat st
City
mashad
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3223 1061
Email
heidarzadeh_2013@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
samane tatari
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
bahjat ts
City
mashad
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3223 1061
Email
tataris1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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