Assessment of the effect of a nutritional readiness care plan on the length of time from non-oral to full-oral nutrition in the hospitalized premature infants in neonatal intensive care unit of Isfahan University of medical Sciences 2011
The present study investigated the effects of nutritional feeding readiness care plan on the length of time from non-oral to full-oral nutrition. The entry criteria included no medical complication such as head and face malformations and intraventricular hemorrhage and excluded criteria included to be NPO or intubation. The 50 preterm infants were recruited from two hospitals of Isfahan( Beheshti and Alzahra) and after parental consent was obtained, were randomized in to experimental and control group (25 males, 25 females) participated in the study that included hospitalized in neonatal intensive care unit. The babies had feeding readiness program for 7 sequential days (twice a day at 4 evening and 9 at night) that started from the first non-oral feeding (gavage) day .Then the length of time from non-oral to full-oral nutrition was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071110249N1
Registration date:2012-08-30, 1391/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-30, 1391/06/09
Registrant information
Name
Somayeh Rostamli
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 0715
Email address
s_rostamli@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing and Midwifary Faculty of Isfahan University of Medical Sciences.
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of a nutritional readiness care plan on the length of time from non-oral to full-oral nutrition in the hospitalized premature infants in neonatal intensive care unit of Isfahan University of medical Sciences 2011
Public title
Assessment of the effect of a nutritional readiness care plan on the length of time from non-oral to full-oral nutrition
Purpose
Supportive
Inclusion/Exclusion criteria
Inclution critria: prematures infants with gestational ages between 28-34 weeks ; after at least 48 hour of oxytion therapy with CPCP High flow ; intubation or o2 flow in incubator ; the first day of non-oral feeding ; they will stay until the end of study.
Exclusive criteria: neonates with head-fatial malformation ; cardiological diseasese with respiratory distress and limbs syanosis ; noromascular malformations ; hydro cephaly ; micro cephaly ; Enteroclysis necrosan ; choronic lung diseases ; Intraventricular hemorrhage( more than grade II) ; Periventricular leukomalacia ; 18 or 21 trisomia ; The proven metabolic diseases ; anticonvalsant drug use ; phototerapy ; sudden change position in neonates with Intraventricular hemorrhage or hypoxia or gastrointestinal diseases such as Enteroclysis necrosan or to be NPO ; or Intubation ; surgical prosidures ; avoiding with doctors orders ; sudden death.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Nursing and Midwifery Faculty,Isfahan Medical University Sciences
Street address
Hezar jarib steert, Isfahan Medical University Sciences
City
Isfahan
Postal code
81746-73461
Approval date
2012-01-17, 1390/10/27
Ethics committee reference number
390433
Health conditions studied
1
Description of health condition studied
prematures feeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
length of time from non-oral to full-oral nutrition
Timepoint
after 7 days
Method of measurement
cheklist
Secondary outcomes
1
Description
jaw and toungh tongue position
Timepoint
full feeding thme
Method of measurement
NOMAS
Intervention groups
1
Description
At first some stimulation (through 3 minutes) for increasing the neonate’s alertness such as audible, tactical, visible and vestibular were done in incubator then infants’ level of alertness was coded from observations based on a modification of the neonatal behavioral assessment scale' state definitions.Then the baby had weighted on a calibrated neonatal scale.Pre-oral phase included stimulation of cheek and lips (with right hand in all participant) through 7 and intra-oral stimulation included of gums, upper palate, into cheeks, middle blade of tonue, and non-nutritive sucking for 7 minutes such table1 and after 1 minutes resting allowed the infant to suck on finger for 2 minutes. After feeding the baby put in prone position and her/his hands put near the mouth.
Category
Treatment - Other
2
Description
The control group put on the cardio-pulmonary monitoring and the researcher only placed her hands from the valves of incubator for 16 minutes infant twice a day but did not touch them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra/ Beheshti hospital
Full name of responsible person
Dr Zohreh Badiee
Street address
Alzahra hosptal,Hezar jarib street,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Medical University Science
Full name of responsible person
Zargham Broujeni Ali
Street address
Hezar jarib street , Nursing and Midwifery Faculty, Isfahan Medical University Science
City
Isfahan
Grant name
Grant code / Reference number
390433
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Medical University Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan Medical University Science
Full name of responsible person
Somayeh Rostamli
Position
MS studant
Other areas of specialty/work
Street address
No 94, fifth race,Milad dormitory, Hezar jarib street.