This is a cross over study which will be done on 35 preterm infants undergoing treatment with nasal positive airway pressure to evaluate the effects of prone and supine positioning on abdominal distention. The setting of this study includes NICUs of Rasule Akram and Akbarabadi hospitals affiliated to Iran University of Medical Sciences. The study population included all the preterm infants admitted in this center. After selecting the samples, the informed consent will obtained from the parents of the babies. Thus, half of the babies in the study first and then lying prone, supine and the other half of the babies in the supine position and then the abdomen will be a lying position and study results will be compared together. Researcher in order to determine abdominal distention in preterm infants with respiratory distress syndrome under continuous positive airway pressure ventilation will record the pressure on the airways and also amount of received milk in a day. After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of waist will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509211788N11
Registration date:2016-01-30, 1394/11/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between supine and prone positions on the abdominal distention in premature infants supported with nasal positive airway pressure.
Public title
The effects of prone and supine positioning on abdominal distention.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infants 32-36 weeks gestational age at birth, birth weight in the range of 1000-2000 g, first and fifth minute Apgar score above 7, the infants who with respiratory distress syndrome that require respiratory assistance, also were not known with revealed congenital disorder and known infection. Infants should be under continuous positive airway pressure ventilation or noninvasive ventilation (Duopap) through the nose with a nasal by prong or mask, under nutrition with breastfeeding or oral gavage.
Exclusion criteria: The infants who with congenital malformations like gastroschisis, omphalocele, myelomeningocele, heart abnormalities. if needs to have surgery or mechanical ventilation through an endotracheal tube, detach of continuous positive airway pressure device, re-feeding of infants in less than 120 minutes at the desired positions will be excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Office Of Vice Chancellor For International Affairs, Iran University Of Medical Sciences, Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
14665-354
Approval date
2015-08-22, 1394/05/31
Ethics committee reference number
IR.IUMS.REC.1394 9213387202
Health conditions studied
1
Description of health condition studied
Abdominal Distention
ICD-10 code
R14
ICD-10 code description
Symptoms and signs involving the digestive system and abdomen Abdominal Distention
Primary outcomes
1
Description
Abdominal distention
Timepoint
After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of abdominal circumference will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other.
Method of measurement
The waist recording will use by the meter paper that be measured 1 cm above the navel.
Secondary outcomes
empty
Intervention groups
1
Description
This cross over study was done on 35 infants who are treated with nasal ventilation positive pressure. After selecting the samples, the informed consent will obtained from the parents of the babies. Thus, half of the babies in the study first and then lying prone, supine and the other half of the babies in the supine position and then the abdomen will be a lying position and results of the study will be compared together. Researcher in order to determine abdominal distention in preterm infants with respiratory distress syndrome under continuous positive airway pressure ventilation will record the pressure on the airways and also amount of received milk in a day. After ensuring of receiving the milk by oral or gavage and after 15 minutes the measurement of abdominal circumference will start. Also before giving positions to register waist with meter paper that the 1 cm above the navel will be measured, waist to stabilize the situation and the loss due to positions prior to 60 minutes before any positions, with meter Paper will be measured by the researcher. It measures 30, 60, 90, 120 minutes after the position ultimately taken scores of abdominal distention in these two positions, will be compared with each other.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Rasoul Akram Iran University of Medical Sciences and Health
Full name of responsible person
Parisa Mohagheghi
Street address
Tehran, Vali-Asr, Vanak Square, Street Rasheed Yassami
City
Tehran
2
Recruitment center
Name of recruitment center
Akbar-Abadi Hospital affiliated to Iran University of Medical Sciences and Health
Full name of responsible person
Parisa Mohagheghi
Street address
Tehran Street molavi- station Paradise Garden
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Campus University of Medical Sciences- Research Center School of Nursing and Midwifer
Full name of responsible person
Lily Borimnejad
Street address
Tehran, Vali-Asr, Vanak Square, Street Rasheed Yassami
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus University of Medical Sciences- Research Center School of Nursing and Midwifer
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
School of Nursing and Midwifery, Iran University
Full name of responsible person
Leili Borimnejad
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran, Vali-Asr, Vanak Square, Street Rasheed Yassami
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
Borimnejad.l@iums.ac.ir- fnm@iums.ac.ir
Web page address
http://fnm.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Mohagheghi
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran, Rashid yasemi st, Valiasr st
City
Tehran
Postal code
14665-354
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
drmohagh@yahoo.com
Web page address
WWW.IUMS.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University
Full name of responsible person
Fatemeh Pourazar
Position
Graduate student neonatal intensive care
Other areas of specialty/work
Street address
Tehran, Valiasr st, Rashid yasemi st
City
Tehran
Postal code
14665-354
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
s_poorazar@yahoo.com
Web page address
http://fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)