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Intervention groups
#1
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 35 and 40 weeks of age equivalent to the postnatal semester age is assessed by TIMP. The control group receiving "routine care" is compared.
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.
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 3534 and 40 weeks of age equivalent to the postnatal semester age is assessed by TIMP. The control group receiving "routine care" is compared.
186 نوزاد نارس بستری با سن کمتر از 32 هفته جنینی در روز 3 الی 7 بعد از تولد بدون ناهنجاری مادرزادی یا مشکل جدی و نبود احتمال مرگ وارد مطالعه می شوند. پس از اعلام رضایت آگاهانه والدین و تخصیص تصادفی نوزادان در "گروه مداخله" و "گروه کنترل"؛ معاینات و ارزیابی بالینی نوزادان نارس برای تعیین سن جنین با ابزار دوبویتز در "هر دو گروه" با تأیید پزشک و ورود نوزادان به مطالعه انجام شد؛ در طول مدت بستری در "گروه مداخله" آموزش کافی به والدین برای شیوه بغل گرفتن و بغل گرفتن به صورت پوست به پوست (مراقبت کانگرویی) داده خواهد شد. حضور والدین در بخش مراقبت ویژه نوزادان بدون محدودیت زمانی برای هر نوع در آغوش گرفتن (بغل گرفتن یا مراقبت کانگرویی) و اثربخشی آن بر رشد عصبی رفتاری در سن 35 و 40 هفتگی معادل سن ترم بعد از تولد با ابزارTIMP بررسی و با "گروه کنترل دریافت کننده مراقبت های روتین" مقایسه می شود.
186 نوزاد نارس بستری با سن کمتر از 32 هفته جنینی در روز 3 الی 7 بعد از تولد بدون ناهنجاری مادرزادی یا مشکل جدی و نبود احتمال مرگ وارد مطالعه می شوند. پس از اعلام رضایت آگاهانه والدین و تخصیص تصادفی نوزادان در "گروه مداخله" و "گروه کنترل"؛ معاینات و ارزیابی بالینی نوزادان نارس برای تعیین سن جنین با ابزار دوبویتز در "هر دو گروه" با تأیید پزشک و ورود نوزادان به مطالعه انجام شد؛ در طول مدت بستری در "گروه مداخله" آموزش کافی به والدین برای شیوه بغل گرفتن و بغل گرفتن به صورت پوست به پوست (مراقبت کانگرویی) داده خواهد شد. حضور والدین در بخش مراقبت ویژه نوزادان بدون محدودیت زمانی برای هر نوع در آغوش گرفتن (بغل گرفتن یا مراقبت کانگرویی) و اثربخشی آن بر رشد عصبی رفتاری در سن 34 و 40 هفتگی معادل سن ترم بعد از تولد با ابزارTIMP بررسی و با "گروه کنترل دریافت کننده مراقبت های روتین" مقایسه می شود.
186 نوزاد نارس بستری با سن کمتر از 32 هفته جنینی در روز 3 الی 7 بعد از تولد بدون ناهنجاری مادرزادی یا مشکل جدی و نبود احتمال مرگ وارد مطالعه می شوند. پس از اعلام رضایت آگاهانه والدین و تخصیص تصادفی نوزادان در "گروه مداخله" و "گروه کنترل"؛ معاینات و ارزیابی بالینی نوزادان نارس برای تعیین سن جنین با ابزار دوبویتز در "هر دو گروه" با تأیید پزشک و ورود نوزادان به مطالعه انجام شد؛ در طول مدت بستری در "گروه مداخله" آموزش کافی به والدین برای شیوه بغل گرفتن و بغل گرفتن به صورت پوست به پوست (مراقبت کانگرویی) داده خواهد شد. حضور والدین در بخش مراقبت ویژه نوزادان بدون محدودیت زمانی برای هر نوع در آغوش گرفتن (بغل گرفتن یا مراقبت کانگرویی) و اثربخشی آن بر رشد عصبی رفتاری در سن 3534 و 40 هفتگی معادل سن ترم بعد از تولد با ابزارTIMP بررسی و با "گروه کنترل دریافت کننده مراقبت های روتین" مقایسه می شود.
Recruitment centers
#1
Name of recruitment center - English: 1- Neonatal intensive care unit of Hazrat Rassol hospital 2- Valiasr hospital
Name of recruitment center - Persian: بخش مراقبت ویژه نوزادان بیمارستان حضرت رسول و بیمارستان ولیعصر
Full name of responsible person - English: Dr Prissa Mohagg
Full name of responsible person - Persian: دکتر پریسا محقق
Street address - English: 1- Sattar khan St, Niayesh St, Mansouri Ave., Hazrat Rasoole Akram hospital, Neonatal intensive care unit. 2- Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospital Neonatal intensive care unit.
Street address - Persian: 1- خیابان ستارخان، خیابان نیایش، فرعی منصوری بیمارستان حضرت رسول اکرم، بخش مراقبت ویژه نوزادان 2- بلوار کشاورز، خیابان غریب. مجتمع بیمارستانی امام خمینی بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: 1449614535
Phone: +49 2164 351000
Fax:
Email: pmohagh@yahoo.com
Web page address:
Name of recruitment center - English: Hazrat Rassol hospital, NICU
Name of recruitment center - Persian: بخش مراقبت ویژه نوزادان بیمارستان حضرت رسول
Full name of responsible person - English: Dr Prissa Mohagg
Full name of responsible person - Persian: دکتر پریسا محقق
Street address - English: 1- Hazrat Rassol hospital, Sattar khan St, Niayesh St, Mansouri Ave.
Street address - Persian: 1- خیابان ستارخان، خیابان نیایش، فرعی منصوری بیمارستان حضرت رسول، بخش مراقبت ویژه نوزادان 2- بلوار کشاورز، خیابان غریب. مجتمع بیمارستانی امام خمینی بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: 1449614535
Phone: +49 2164 351000
Fax:
Email: pmohagh@yahoo.com
Web page address:
Name of recruitment center - English: 1- Neonatal intensive care unit of Hazrat Rassol hospital 2- Valiasr hospital, NICU Name of recruitment center - Persian: بخش مراقبت ویژه نوزادان بیمارستان حضرت رسول و بیمارستان ولیعصر Full name of responsible person - English: Dr Prissa Mohagg Full name of responsible person - Persian: دکتر پریسا محقق Street address - English: 1- Hazrat Rassol hospital, Sattar khan St, Niayesh St, Mansouri Ave., Hazrat Rasoole Akram hospital, Neonatal intensive care unit. 2- Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospital Neonatal intensive care unit. Street address - Persian: 1- خیابان ستارخان، خیابان نیایش، فرعی منصوری بیمارستان حضرت رسول اکرم، بخش مراقبت ویژه نوزادان 2- بلوار کشاورز، خیابان غریب. مجتمع بیمارستانی امام خمینی بیمارستان ولیعصر بخش مراقبت ویژه نوزادان City - English: Tehran City - Persian: تهران Province: Tehran Country: Germany Postal code: 1449614535 Phone: +49 2164 351000 Fax: Email: pmohagh@yahoo.com Web page address:
#2
Name of recruitment center - English: 2- Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospita
Name of recruitment center - Persian: - بلوار کشاورز، خیابان غریب. مجتمع بیمارستانی امام خمینی بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
Full name of responsible person - English: Dr ziba Mosaybi
Full name of responsible person - Persian: دکتر زیبا مسیبی
Street address - English: Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospital Neonatal intensive care unit.
Street address - Persian: بلوار کشاورز خیابان دکتر قریب، مجموعه ی بیمارستانی امام خمینی، بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +49 2161 192359
Fax:
Email: mosayebiir@yahoo.com
Web page address:
Name of recruitment center - English: Vali-e-Asr hospital, NICU
Name of recruitment center - Persian: بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
Full name of responsible person - English: Dr ziba Mosaybi
Full name of responsible person - Persian: دکتر زیبا مسیبی
Street address - English: Vali-e-Asr hospital, NICU.,Keshavarz Blvd. Gharib St.
Street address - Persian: بلوار کشاورز خیابان دکتر قریب، بیمارستان ولیعصر بخش مراقبت ویژه نوزادان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +49 2161 192359
Fax:
Email: mosayebiir@yahoo.com
Web page address:
Name of recruitment center - English: 2- Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospitahospital, NICU Name of recruitment center - Persian: - بلوار کشاورز، خیابان غریب. مجتمع بیمارستانی امام خمینی بیمارستان ولیعصر بخش مراقبت ویژه نوزادان Full name of responsible person - English: Dr ziba Mosaybi Full name of responsible person - Persian: دکتر زیبا مسیبی Street address - English: KeshavarzVali-e-Asr hospital, NICU.,Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex Imam Khomeini hospital complex (IKHC) comprises Vali-e-Asr hospital Neonatal intensive care unit. Street address - Persian: بلوار کشاورز خیابان دکتر قریب، مجموعه ی بیمارستانی امام خمینی، بیمارستان ولیعصر بخش مراقبت ویژه نوزادان City - English: Tehran City - Persian: تهران Province: Tehran Country: Germany Postal code: ۱۴۱۹۷۳۳۱۴۱ Phone: +49 2161 192359 Fax: Email: mosayebiir@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: payam noor university
Name of organization / entity - Persian: دانشگاه پیام نور
Full name of responsible person - English: Dr Mahnaz Aliakbari
Full name of responsible person - Persian: دکتر مهناز علی اکبری
Street address - English: Nakhl Street, Artesh Highway, Mini City
Street address - Persian: آدرس: تهران، مینی سیتی، بلوار ارتش، اول شهرک نفت، خیابان نخل، سازمان مرکزی دانشگاه پیام نور
City - English: Teharan
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: 43183-14556
Phone:
Fax:
Email: int@pnu.ac.ir
Web page address: http://www.pnu.ac.ir
contact.organization_id:
Name of organization / entity - English: payam noor university
Name of organization / entity - Persian: دانشگاه پیام نور
Full name of responsible person - English: Dr Mahnaz Aliakbari
Full name of responsible person - Persian: دکتر مهناز علی اکبری
Street address - English: Nakhl Street, Artesh Highway, Mini City, central organization, Payame Noor University Tehran
Street address - Persian: آدرس: تهران، مینی سیتی، بلوار ارتش، خیابان نخل، سازمان مرکزی دانشگاه پیام نور
City - English: Teharan
City - Persian: تهران
Province: Tehran
Country: Germany
Postal code: 43183-14556
Phone: +49 9122 234260
Fax:
Email: int@pnu.ac.ir
Web page address: http://www.pnu.ac.ir
contact.organization_id: Name of organization / entity - English: payam noor university Name of organization / entity - Persian: دانشگاه پیام نور Full name of responsible person - English: Dr Mahnaz Aliakbari Full name of responsible person - Persian: دکتر مهناز علی اکبری Street address - English: Nakhl Street, Artesh Highway, Mini City, central organization, Payame Noor University Tehran Street address - Persian: آدرس: تهران، مینی سیتی، بلوار ارتش، اول شهرک نفت، خیابان نخل، سازمان مرکزی دانشگاه پیام نور City - English: Teharan City - Persian: تهران Province: Tehran Country: Germany Postal code: 43183-14556 Phone: +49 9122 234260 Fax: Email: int@pnu.ac.ir Web page address: http://www.pnu.ac.ir
Protocol summary
Study aim
Study parent participation care in neurobehavioral development of premature infants in the neonatal intensive care unit
Design
A clinical trial with blinded the analyzer, with parallel group design of 186 premature infants, randomized, random allocation using Excel software.
Settings and conduct
1. Hazrat Rassol hospital, Neonatal intensive care unit
2. Vali-e-Asr hospital, Neonatal intensive care unit.
Participants/Inclusion and exclusion criteria
- 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
Intervention groups
- 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.
Main outcome variables
Neuromuscular development:
1. including joints, wrists, elbows, shoulders, ankles, knees, and thighs
2. Sucking and breastfeeding
General information
Reason for update
Acronym
PPC
IRCT registration information
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
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study Parent Participation Care in neurobehavioral development of preterm infants in the neonatal intensive care unit
Public title
The effect of parent participation care on premature infants neurobehavioral development
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 180 days old to 280 days old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
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
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
- 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.
Disorders of newborn related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
1. Heart rate
Timepoint
1. Before, during and after intervention
Method of measurement
1. pulse oximeter monitoring device
2
Description
2. Respiration rate
Timepoint
2. Before, during and after intervention
Method of measurement
2. pulse oximeter monitoring device
3
Description
3. oxygen saturation level
Timepoint
3. Before, during and after intervention
Method of measurement
3. pulse oximeter monitoring device
4
Description
4. Behavioral responses
Timepoint
4. Before, during and after intervention
Method of measurement
4. The Neonatal Behavioral Assessment Scale
5
Description
5. Indicators of neuromotoral function
Timepoint
5. at 35 and 40 weeks of age
Method of measurement
5. The Test of Infant Motor Performance (TIMP)
Secondary outcomes
1
Description
1. Neurobehavioral development
Timepoint
1. At the age of ≤32 weeks 2. At the age of 35 weeks 3. At the age of 40 weeks
Method of measurement
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
Description
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.