This is a quasi-experimental study which was performed in NICU of Alzahra hospital in Tabriz from Apr 20 to November 5th, 2011. Sixty premature infants with low birth weight were studied. Both the control and intervention groups involved 30 samples. The appropriation of these two groups for the infants was non-random and simple by sampling where at first the control group and then the intervention group were specified regarding the probability of information transferring and contacting between mothers. The control group infants received the routine trainings of the ward for relactation from the nurses. The trainings were sporadic, done in less time and without enough follow-up. But the experimental group received the supportive training of relactation in an organized procedure in addition to the routine trainings mentioned above. This procedure included: recommending taking the prescribed pills consistently, consuming more liquid and protein-rich foods, using electrical or hand pumping for each breast every 2 or 3 hours for 15 to 20 minutes, and performing KMC twice a day each time at least for 60 minutes. The supportive acts in the experimental group were performed through the following steps: 1.Creating an appropriate training environment 2. The nursing support was provided by a trained researcher 3. Consulting the mothers was performed face to face and individually and daily. Both groups were followed for 14 days. The frequency of breastfeeding and feeding with formula, KMC and daily weight were measured and recorded in the information collecting form by the co- researcher who wasn't informed about the type of infants' group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304044613N10
Registration date:2013-04-21, 1392/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational & Supportive Relactation Program on Weight Gaining of Preterm Infants in Neonatal Intensive Care
Public title
The Effect of Relactation Program on Weight Gaining of Preterm Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria for infants: immature infants under 2 months, hospitalized in nursery or NICU) without congenital anomalies or nervous problems, cardio - vascular hereditary diseases and injuries during labor, who had not contraindication for breast feeding - single baby. Criteria for mothers: mothers with infants under 2 months - decreased the mother’s milk and more than half of infant breast feeding is provided by supplementary feeding - mothers who had not feeding her baby at least a week and a maximum of four weeks. Mothers had with stable physical and mental condition and willing to breast feeding of their baby - in the mother's breast examination there are not any breast problems such as abscesses, systemic diseases, mastitis, depressed nipples shall interfere with breastfeeding.
Exclusion criteria for infants: contraindicated breastfeeding during intervention period - diagnosis of neurological problems, cardiovascular disease and congenital anomalies in infants during intervention period. Exclusion criteria for mothers: lack of cooperation for breastfeeding.
Age
To 2 years old
Gender
Both
Phase
N/A
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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Preterm
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Gholghasht St.
City
Tabriz
Postal code
Approval date
2011-05-01, 1390/02/11
Ethics committee reference number
5/4/1133
Health conditions studied
1
Description of health condition studied
Neonatal difficulty in feeding at breast
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Weight Gaining of preterm infant
Timepoint
1- 14
Method of measurement
Ska digital devices for infant
Secondary outcomes
empty
Intervention groups
1
Description
infants in control group receives routine training, includes recommendations for Shyrafza drugs (metoclopramide Vshyrafzay plant), breast milk pUmping by hand or pump your KMC By Nursing Staffs.
Category
Other
2
Description
infants of exprimental group in addition to the routine training, recieved educational support program that includes Supportive-educative relactition program includes recommendations for regular doses of prescription pills ¬, more fluid and protein foods, keep using the hand pump or electric 3-2 hours for 20-15 minutes every breast and KMC regularly 2 times a day for at least 60 minutes. and daily encouragement and Fallowup by the one of researcher . Supportive exercises in this groups includes: 1) creating a conducive environment for learning (training in relactation rooms and an evening shift was part of the training was to prepare the mother calmly). 2) supported by a trianed nurse (give data in relation to relactition to mothers).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Nahid Dehkhoda
Street address
Alzahra hospital , Baghshomal Square, Artesh St.
City
Tbriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Nursing & Midwifery Faculty, Shariaty St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nahid Dehkhoda
Position
NICU Master degree Nursing student
Other areas of specialty/work
Street address
Tabriz Nursing & Midwifery Faculty
City
Tabriz
Postal code
51668-44199
Phone
+98 41 1479 0365
Fax
+98 41 1479 6969
Email
n.dehkhoda@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)