Protocol summary
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Study aim
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Comparison of neonate nutritional behavior score between two groups on days 1,2,3,4,5 after intervention with baseline score control
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Design
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Randomized clinical trial with control group, parallel, sample size of 80
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Settings and conduct
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This study is a randomized controlled clinical trial. After obtaining permission from the Ethics Committee and registration at Iran Clinical Trials Center, the researcher will begin the daily sampling of 80 premature neonates in Alzahra and Taleghani Hospitals through convenience sampling. After evaluating inclusion and exclusion criteria, the goals and methods will be explained to mothers.
Samples will be randomly divided and stratified based on neonate`s age (31-32,6 and 33-35 weeks old) with blocks size 4 , 6 with 1:1 ratio in two groups: intervention group, 3 times of daily care once by mother and twice by surrogate in the last two times of care and the control group 3 times of daily care by mother (up to 5 days each time 60 minutes).Allocation sequences will be determined using RAS. Allocation concealment will be done using opaque-sealed envelopes numbered in sequence and opened by someone other than the researcher. Nutritional behavior will be measured using the Preterm Infant Breastfeeding Behavior Scale and physiological outcomes; temperature will be measured with a thermometer; heart-rate and arterial oxygen saturation will be checked with Pulse-oximeter; respiratory rate will be tested by chest touch and observation once before intervention and once again afterwards for up to 5 days.
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Participants/Inclusion and exclusion criteria
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31-35 weeks neonates, weighing more than 1500 g and no connection to ventilator
Gravida 1,2
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Intervention groups
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Intervention: Three times a day of care, once by mother - two times surrogate
Control:Three times a day of mother's care
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Main outcome variables
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Nutritional behavior score of preterm infant
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150424021917N10
Registration date:
2020-04-22, 1399/02/03
Registration timing:
prospective
Last update:
2021-01-21, 1399/11/02
Update count:
1
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Registration date
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2020-04-22, 1399/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-04, 1399/02/15
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Expected recruitment end date
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2020-10-06, 1399/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial
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Public title
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The effect of kangaroo care by mother and surrogate on nutritional behavior of preterm neonates : A randomised controlled clinical trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Gravida 1,2
31-35 weeks neonates
Neonate weight more than 1500 g
unfixed female surrogate
Exclusion criteria:
Neonatal sepsis
Neonate connection to ventilator
CPAP use
Catheter in umbilical vein
Prescribing any medication to the neonate that may affect it's sleep
Neonate intra ventricular hemorrhage
Cleft lips and cleft palate
Mother's epilepsy or surrogate
Mother’s or surrogate’s addiction to any drug
New scare in part of mother’s/surrogate’s body that is in direct contact with baby's
Skin rash
Use of perfume and perfume soap
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Age
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From 217 days old to 245 days old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples will be randomly divided and stratified based on neonate`s age (31-32,6 and 33-35 weeks old) with 4 and 6 blocks with 1:1 ratio in two groups: intervention and control groups. Allocation sequences will be determined using RAS. Allocation concealment will be done using opaque-sealed envelopes numbered in sequence and opened by someone other than the researcher.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-03, 1398/11/14
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Ethics committee reference number
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IR.TBZMED.REC.1398.1213
Health conditions studied
1
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Description of health condition studied
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Preterm neonates
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ICD-10 code
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P07.33
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ICD-10 code description
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Preterm newborn, gestational age 30 completed weeks
Primary outcomes
1
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Description
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Nutritional behavior of preterm neonate
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Timepoint
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Once before the intervention and once again after the intervention for up to 5 days
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Method of measurement
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Using the questionnaire Preterm Infant Breastfeeding Behavior Score (PIBBS)
Secondary outcomes
1
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Description
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Nutritional effect
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Timepoint
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once before the intervention and once again after the intervention for up to 5 days
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Method of measurement
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With using of standard questionnare
2
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Description
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Physiological function of preterm neonate (heart rate, temperature, respiratory rate and arterial oxygen saturation)
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Timepoint
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once before the intervention and once again after the intervention for up to 5 days
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Method of measurement
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temperature will be measured with a thermometer; heart-rate and arterial oxygen saturation will be checked with Pulse-oximeter; respiratory rate will be tested by chest touch and observation.
Intervention groups
1
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Description
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Intervention group: Mother/surrogate kangroo care, 3 times of daily care once by mother and twice by surrogate in the last two time of care up to 5 days each time 60 minutes
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Category
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Behavior
2
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Description
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Control group: 3 times of daily care by mother up to 5 days each time 60 minute
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only part of the information, such as information on the main outcome or the like, can be shared.
The results of clinical study will be published as article.
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When the data will become available and for how long
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Start publishing period 6 months after printing results.
Immediately after publishing the results.
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Scientific using with citation to article
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From where data/document is obtainable
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Sevil Hakimi hakimis@tbzmed.ac.ir
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What processes are involved for a request to access data/document
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The applicant sends an application via e-mail. After receiving the email, the results will be sent.
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Comments
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