Protocol summary
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Study aim
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Study parent participation care in neurobehavioral development of premature infants in the neonatal intensive care unit
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Design
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A clinical trial with blinded the analyzer, with parallel group design of 186 premature infants, randomized, random allocation using Excel software.
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Settings and conduct
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1. Hazrat Rassol hospital, Neonatal intensive care unit
2. Vali-e-Asr hospital, Neonatal intensive care unit.
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Participants/Inclusion and exclusion criteria
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- Premature babies
- Infant age ≤32 weeks with ≤1500 grams
- Stable physiological state (pulse, respiration, oxygen saturation) and temperature
- No need for mechanical ventilation
- Mothers and fathers of premature infants should not take neuroleptic drugs and opioid
- Parents live together
Exclusion criteria:
- Dissatisfaction of parents for any reason
- The possibility of brain abnormalities and other physical abnormalities as well as other problems such as:
- Intraventricular bleeding and necrotizing enterocolitis
- Continuous instability of physiological conditions (pulse, respiration and oxygen saturation of blood)
- The possibility of infant death in the first days of life
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Intervention groups
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- Intervention group receive unlimited time parents holding (held in arms and skin-to-skin care)
- Control group receive routine care
- Duration held skin-to skin will investigated on neurobehavioral outcome and compared with control group.
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Main outcome variables
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Neuromuscular development:
1. including joints, wrists, elbows, shoulders, ankles, knees, and thighs
2. Sucking and breastfeeding
General information
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Reason for update
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Acronym
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PPC
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IRCT registration information
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IRCT registration number:
IRCT20140604017972N14
Registration date:
2021-05-18, 1400/02/28
Registration timing:
prospective
Last update:
2021-10-26, 1400/08/04
Update count:
1
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Registration date
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2021-05-18, 1400/02/28
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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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2021-06-20, 1400/03/30
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Expected recruitment end date
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2021-10-22, 1400/07/30
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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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Study Parent Participation Care in neurobehavioral development of preterm infants in the neonatal intensive care unit
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Public title
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The effect of parent participation care on premature infants neurobehavioral development
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
- Parents signed informed consent. - Singleton born premature infants ≤ 32 weeks - weighing less than <1500g gestational age - enrolled the first born in 3-7 days of life. - Mothers should not take any psychiatric medication and any drug abuse - fathers should not take any psychiatric medication and any drug abuse - Parents live together.
Exclusion criteria:
- without any: - congenital physical and cerebral seizure - Intraventricular and Intracerebral hemorrhage - Persistent instability of physiological conditions (pulse respiration and oxygen saturation of blood). - necrotizing enterocolitis. -Those infants expected to expire within the first days of life were excluded.
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Age
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From 180 days old to 280 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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Sample size
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Target sample size:
186
More than 1 sample in each individual
Number of samples in each individual:
2
- One person: gets parental care: hug and hug skin to skin (kangaroo care) - One person in control: gets routine care
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The allocation is made for each newborn as a randomization unit and by a randomized balanced block method (without stratification) is done with a predetermined block size. Using excel software, which assigns each baby to two groups, with sequential numbers and attached to their forms in opaque sealed envelopes. This is done by one of our colleagues who is not involved in the study and hided the randomization list until the statistical analysis
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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- The parents and their infants are directly involved as executor and the control group don’t receive any intervention, can't be blinded them.
- Regarding the researcher who is as the executor of the study in the field, and teach parents how to perform the intervention and follow the consequences and examinations, can't be blinded any of them.
- The only person who kept concealed is the data analyzer, he will analyzed groups named A and B.
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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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2021-01-26, 1399/11/07
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Ethics committee reference number
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IR.PNU.REC.1399.154
Health conditions studied
1
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Description of health condition studied
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1. Born at preterm 2. Low birth weight
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ICD-10 code
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P07
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ICD-10 code description
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Disorders of newborn related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
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Description
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1. Heart rate
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Timepoint
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1. Before, during and after intervention
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Method of measurement
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1. pulse oximeter monitoring device
2
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Description
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2. Respiration rate
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Timepoint
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2. Before, during and after intervention
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Method of measurement
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2. pulse oximeter monitoring device
3
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Description
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3. oxygen saturation level
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Timepoint
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3. Before, during and after intervention
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Method of measurement
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3. pulse oximeter monitoring device
4
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Description
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4. Behavioral responses
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Timepoint
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4. Before, during and after intervention
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Method of measurement
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4. The Neonatal Behavioral Assessment Scale
5
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Description
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5. Indicators of neuromotoral function
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Timepoint
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5. at 35 and 40 weeks of age
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Method of measurement
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5. The Test of Infant Motor Performance (TIMP)
Secondary outcomes
1
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Description
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1. Neurobehavioral development
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Timepoint
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1. At the age of ≤32 weeks 2. At the age of 35 weeks 3. At the age of 40 weeks
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Method of measurement
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1. Dubowitz Scale: To assessment neurological, physical criteria and to determine gestational age at birth. 2. TIMP: Is a motor outcome to assess the posture and selective control of movement needed by infants for functional performance in daily life. 3. TIMP: Is a motor outcome to assess the posture and selective control of movement needed by infants for functional performance in daily life.
Intervention groups
1
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Description
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186 hospitalized premature infants’ ≤32 weeks of gestation are included in the study on days 3 to 7 after birth without congenital anomalies or serious problems and lack of chance of death. After announcing the informed consent of the parents and the random assignment of the infants in the "intervention group" and the "control group"; Examinations and clinical evaluation to determine fetal age will performed with Dubowitz instrument in "both groups" after physician approval for "intervention group", parents will be given sufficient training on how to hug and hug skin to skin (kangaroo care). The presence of parents in the nicu with no time limit for any type of cuddling (hugging or kangaroo care) and its effectiveness on behavioral neurodevelopment at 34 and 40 weeks of age equivalent to the postnatal semester age is assessed by TIMP. The control group receiving "routine care" is compared.
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Category
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Prevention
2
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Description
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Control group: take nicu routine care
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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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Payame Noor University
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Grant code / Reference number
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دانشگاه پیام نور
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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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payam noor university
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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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Private
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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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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1- study tools and statistical data from the whole data
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When the data will become available and for how long
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6 months after end of study
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To whom data/document is available
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Neonatologists, Neonatal Intensive Care Nurses, Neonatal Occupational Therapists
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Under which criteria data/document could be used
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The family-centered Interventions in the intensive care units favored the overall neurobehavioral performance in VLBW preterm infants at term age.
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From where data/document is obtainable
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Zahra Godarzi
godarziz@tums.ac.ir
Tell: 00989122072918
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What processes are involved for a request to access data/document
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By Email is the best way to have contact in short time
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Comments
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