The aim of this study is to determine the abdominal palpation on the prevention of feeding intolerance in preterm infants. The study population includes 54 premature infants that hospitalizes in neonatal intensive care units and nurseries. They will be selected based on inclusion and exclusion criteria (such as 28 to 32 weeks of gestational age ; 1800-1000Grm weight and no abnormal naso pharyngeal area) placed nonrandomly in two groups, by using the cart.The first baby that be entered to NICU, assigned to the intervention or control group randomly and then, newborns are placed next to intervention and control groups, respectively. The research intervention is a kind of palpation that performs on the abdomen for 15 minutes. Palpation technique will be done by the researcher for 4 days and 2 times a day (once in the morning, once at night) in the intervention group. During this period, vomiting and stool also will be recorded. On the fifth day, the result will be compared with control group.The main outcome of this study is feeding tolerance. Feeding tolerance promotes preterm infants. In this intervention, Olive oil is used for every touch section. Olive oil creates less sensitivity in newborns.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102430474N1
Registration date:2017-02-24, 1395/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-24, 1395/12/06
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
by my own
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the effect of abdominal palpation on the prevention of feeding intolerance in the right lateral position and heads-up in premature infants.
Public title
Determine the effect of abdominal palpation on feeding tolerance in preterm infants.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with 28-32 weeks age; 1800-1000Grm weight; no swallowing reflex; getting enough through the mouth; present of effective swallowing
exclusion criteria: abnormal nasopharyngeal area; sepsis; Necrotizing Enterocolitis; obstruction and bowel surgery; cleft lip and cleft palate; intraventricular hemorrhage; the recent restoration of the esophagus; heart disease; respiratory support needs; physiological instability; Changes in baby conditions that cause fasting or require to mechanical ventilation through continuous positive airway pressure.
Age
From 28 days old to 31 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Newborns, based on the date of entry into the neonatal intensive care unit and based on inclusion criteria, will be placed in intervention and control groups respectively. The first newborn entered in the neonatal intensive care unit, was located in the intervention group and next newborn was placed in control group. This process continues until sampling was done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of International Branch of Shahid Beheshti University of Medical Science
Street address
Number 19, Shahid Abbasspour St., vali-asr Ave.,
City
Tehran
Postal code
141553693
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.221
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
prevention of feeding intolerance
Timepoint
5 dayes
Method of measurement
Using charts available in the Neonata lIntensive Care Unit
Secondary outcomes
empty
Intervention groups
1
Description
Abdominal palpation in the intervention group.
Category
Prevention
2
Description
No palpation of the abdomen in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari hospital affiliated with the Urmia University of Medical Sciences