Protocol summary
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Study aim
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Determining the effect of participation in the oral-pharyngeal administration of colostrum on the anxiety of mothers of premature babies hospitalized in the neonatal intensive care unit
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Design
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Randomized clinical trial, the sample size is 148 people, the random list of people is prepared through the website http://randomisation.ir.
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Settings and conduct
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This research is a clinical trial that is conducted in Shahid Akbarabadi State Hospital in Tehran. The researcher invites eligible research units to cooperate in the study. Eligible mothers will be randomly divided into intervention and control groups. Before and 24 hours after the intervention, the situational trait anxiety questionnaire is completed by the mothers of both groups.
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Participants/Inclusion and exclusion criteria
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Mothers of premature babies
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Intervention groups
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During the first 24 hours after birth, the mothers of the intervention group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time for 48 hours, and the researcher injects the milk with a 1 ml syringe without a needle. It is given to the baby, in the presence of the mother and under the supervision of a neonatologist. The tip of the syringe is placed in the baby's mouth along the right buccal mucosa towards the oropharynx and the volume of 0.1 ml is prescribed, and without removing the syringe from the baby's mouth, 0.1 ml is also administered in the left buccal. Mothers in the control group are not given milk to feed their babies, and according to the department's routine, when the doctor orders them to start breastfeeding.
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Main outcome variables
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Maternal anxiety
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:
IRCT20200120046200N3
Registration date:
2022-11-14, 1401/08/23
Registration timing:
registered_while_recruiting
Last update:
2023-02-16, 1401/11/27
Update count:
2
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Registration date
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2022-11-14, 1401/08/23
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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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2022-10-23, 1401/08/01
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Expected recruitment end date
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2023-07-23, 1402/05/01
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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 participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants admitted to neonatal intensive care unit
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Public title
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The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ages 18 years and above
Willingness to breastfeed
Understanding and speaking ability in Persian language
Willing to manually express milk or use of a manual or electric breast pump in the first 24 hours after delivery
mother's presence in the hospital during the study period
Gestational age less than 32 weeks or birth weight less than 1500 grams
Being NPO for infant
Stable vital signs for infant
Exclusion criteria:
Mother's suffering from psychological disorders requiring medication based on mother's self-report
History of drug and psychoactive abuse
Surgery or breast problems such as abscess, inverted nipple, mastitis or cancer
Having diseases contrary to breastfeeding such as AIDS, active pulmonary tuberculosis
Occurrence of stressful events during the study period
Hospitalization of the mother after delivery in departments other than postpartum
No grade 3 and 4 intraventricular hemorrhage
Absence of pH less than 6 in the fifth minute after birth
Absence of abnormalities in the infant based on medical records
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Age
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From 18 years 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:
148
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4-block method with placement. The random list of people is prepared through the website http://randomisation.ir.
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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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2022-10-04, 1401/07/12
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Ethics committee reference number
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IR.IUMS.REC.1401.555
Health conditions studied
1
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Description of health condition studied
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The effect of participation in the oral-pharyngeal administration of colostrum on the anxiety of mothers of premature babies hospitalized in the neonatal intensive care unit
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ICD-10 code
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Z63.7
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ICD-10 code description
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Other stressful life events affecting family and household
Primary outcomes
1
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Description
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Maternal anxiety
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Timepoint
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Before the intervention, 24 hours after the intervention
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Method of measurement
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State Trait Anxiety Inventory(STAI)
Intervention groups
1
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Description
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Intervention group: During the first 24 hours after giving birth, the mothers of the test group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time in the morning and evening shifts for 48 hours, and the researcher injects the expressed colostrum with a 1 ml syringe, without The head of the needle is given to the baby three times a day, in the presence of the mother and under the supervision of a newborn doctor. In this way, the tip of the syringe is placed in the baby's mouth along the right buccal mucosa and is directed to the oropharynx, and the volume of 0.1 ml is prescribed, and without removing the syringe from inside the baby's mouth, the left buccal is also 0.1 ml. ml is repeated in the mentioned method. A total of 0.2 ml is prescribed in each session. Mothers in the control group do not receive milk to feed the baby, and they express their milk and deliver it to the neonatal intensive care unit according to the department's routine when the doctor orders to start breastfeeding and feeding the baby.
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Category
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N/A
2
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Description
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Control group: Mothers in the control group are not given milk to feed the baby, and according to the department's routine, when the doctor orders to start breastfeeding and feeding the baby, they express their milk and deliver it to the neonatal intensive care unit.
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Category
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N/A
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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Iran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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