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Impact of developmental care on length of stay in infant undergoing mechanical ventilation

Protocol summary

Summary
This is a quasi-experimental study was done to investigate the impact of developmental care on length of mechanical ventilation on 60 inpatient neonates who undergo mechanical ventilation at 4 hospital affiliated to Shahid Beheshti University of Medical Sciences. A convenience sample was selected from 4 hospital in Tehran, Iran that nonrandomly assigned to interventinal from Mahdieh Hospital (n=30) and control group (n=30) from other 3 hospital (Mofid Childrenʼs Hospital, Imam Hossein Hospital and Shohada Tajrish Hospital). Inclusion criteria: gestational age less than 33 weeks with birth weight equal or less than 2500 g; neonates suffered from respiratory distress syndrome; mechanical ventilation> 24 hours of first 48 hours of life and exclusion criteria: treatment with surfactant, congenital anomalies; asphyxia; respiratory disorders; cyanotic heart disease; mouth and facial abnormalities; maternal use of opium drugs during pregnancy; neonatal death; intraventricular hemorrhage (grade 3 or 4 ) alongside hydrocephalus; sepsis, necrotizing enterocolitis; growth disorders; bronchopulmonary dysplasia; patent ductus arteriosus requiring treatment; pneumonia caused by mechanical ventilation. Data collection included demographic information that completed under supervision of researchers in the hospitals for intervention groups. Developmental care intervention consist of: change the position every 2-3 hours, hand near face, nesting, Right side or prone position to improve gastric emptying and reduce the effects of gastroesophageal reflux, non-nutritive sucking before invasive intervention and gavage, Using gentle and quiet handling techniques, trunk flexion, shoulder and hip flexion and adduction, prevent suddenly change position and Keep hands of care keeper over the baby's head before beginning any care for providing the infant's sense of care. Care in the intervention group was maintained until the end of the need for mechanical ventilation. Daily nursing care for infants in the control group was conducted.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015070123003N1
Registration date: 2015-08-09, 1394/05/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-09, 1394/05/18
Registrant information
Name
Sima Sabaghi Faradonbeh
Name of organization / entity
International Branch of Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 38 3422 6542
Email address
manighea@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of developmental care on length of stay in infant undergoing mechanical ventilation
Public title
Developmental care
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: gestational age less than 33 weeks with birth; weight equal or less than 2500 g; neonates suffered from respiratory distress syndrome; mechanical ventilation > 24 hours of first 48 hours of life. Exclusion criteria: treatment with surfactant; congenital anomalies; asphyxia; respiratory disorders; cyanotic heart disease; mouth and facial abnormalities; maternal use of opium drugs during pregnancy; neonatal death; intraventricular hemorrhage ( grade 3 or 4) alongside hydrocephalus; sepsis; necrotizing enterocolitis ; growth disorders; bronchopulmonary dysplasia; patent ductus arteriosus requiring treatment; pneumonia caused by mechanical ventilation.
Age
To 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
The ethics committee of International Branch of Behesti University of Medical Sciences and Health S
Street address
No.19, Next to Hemat bridge, Street SHahid Abbaspoor, Vali asr(AJ), Tehran
City
Tehran
Postal code
14155-3693
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
1000/912

Health conditions studied

1

Description of health condition studied
respiratory distress syndrome
ICD-10 code
p 22.0
ICD-10 code description
Hyaline membrane disease

Primary outcomes

1

Description
Developmental care
Timepoint
after intervention
Method of measurement
Data collection included three part demographic questioner. First part, demographic information including weight, sex, age, type of birth, apgar score at the first minute, apgar score at 5 minute that completed under supervision of researchers at the hospitals for intervention groups. Secondary part including developmental care interventions consist of: change the position every 2-3 hours, hand near face, nesting, Right side or prone position to improve gastric emptying and reduce the effects of gastroesophageal reflux, non-nutritive sucking before invasive intervention and gavage, Using gentle and quiet handling techniques, trunk flexion, shoulder and hip flexion and adduction, prevent suddenly change position and Keep hands of care keeper over the baby's head before beginning any care for providing the infant's sense of care and third part including the onset and end time that need for mechanical ventilation.

Secondary outcomes

1

Description
Duration of mechanical ventilation
Timepoint
Since the beginning of mechanical ventilation until maintained until the end of the need for mechanical ventilation.
Method of measurement
Number of days

Intervention groups

1

Description
Researcher in NICƯ Mahdieh Hospital will present and in relation with the developmental intervention, required explanations will give to nurses. In researcher initially will introduce herself and objectives to the parents of neonates who had inclusion criteria for the study and will sign an informed consent by parents. Then, the first part of a demographic questionnaire will complete by the researcher and the date of onset of mechanical ventilation will record. Developmental care interventions will receive by all neonates who had eligible for inclusion through a trained nurse. Care in the intervention group will maintain until the end of the need for mechanical ventilation.
Category
N/A

2

Description
Inpatient neonates of NICUS̛ Mofid Children's Hospital, Imam Hossein and Shohada Tajrish, Tehran as the control group will receive daily care. Researcher in theses hospitals will attend and demographic information questionnaire will fulfill, also the onset and end time that need for mechanical ventilation for 30 cases will record.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Seyyed Abolfazl Afje
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Mofid Childrens Hospital
Full name of responsible person
Minoo Fallahi
Street address
Shariati Ave, Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Ms. Shahrinani
Street address
Madani Ave, Tehran, Iran
City
Tehran

4

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Mahta Fateme Basir
Street address
Tajrish Sq., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
-
Full name of responsible person
-
Street address
-
City
-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
-
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
International Branch of Beheshti University of Medical Science and Health Services
Full name of responsible person
Sima Sabaghi Faradonbeh
Position
Master student
Other areas of specialty/work
Street address
No19, Next to Hemat bridge, Street SHahid Abbaspoor, , Vali asr(AJ), Tehran
City
Tehran
Postal code
14155-3693
Phone
+98 21 8820 9020
Fax
+98 21 8864 9181
Email
ib@sbmu.ac.ir
Web page address
www.ivbs.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
SHahid Beheshti University of Medical Science, School of Nursing and Midwifery
Full name of responsible person
Manigheh Nourian
Position
Science Committee
Other areas of specialty/work
Street address
Niayesh Complex, Niayesh Cross Road, Vali Asr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
sbnmf@sbmu.ac.i
Web page address
www.nm.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
International Branch of Beheshti University of Medical Science and Health Services
Full name of responsible person
Sima Sabaghi Faradonbeh
Position
Master student
Other areas of specialty/work
Street address
No 19, Next to Hemat bridge, Street SHahid Abbaspoor, Vali asr(AJ), Tehran
City
Tehran
Postal code
14155-3693
Phone
+98 21 8820 9020
Fax
+98 21 8864 9181
Email
ib@sbmu.ac.ir
Web page address
www.ivbs.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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