Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003308495 Date of Approval: 07/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Multi-Sensory Stimulation Program in High-Risk Neonates.
Official scientific title Neurobehavioral Response to Multi-Sensory Stimulation Program in High-Risk Neonates.
Brief summary describing the background and objectives of the trial High-risk neonates admitted to the neonatal intensive care unit (NICU) are suffering from lack of sensory experiences which are vital for normal brain development, rather is exposed to excessive or inappropriately timed stimulation in the NICU that leads to deleterious effects on premature infants whose brains are immaturely developed.The aim of this study was to investigate the effect of multi-sensory stimulation program on neurobehavioral development in high- risk neonates.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied High-risk neonates,Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/09/2017
Actual trial start date 17/09/2017
Anticipated date of last follow up 20/02/2018
Actual Last follow-up date 25/02/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Stopped early/ terminated
Publication URL http://www.bfpt.eg.net/
Secondary Ids Issuing authority/Trial register
Research Ethical Committee of Faculty of PhysicalTherapy ¿ Cairo University P.T.REC/012/001847
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using sealed envelopes Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group routine medical and nursery 2 successive weeks A neonatologist has reviewed the medical charts daily and also has prescribed the necessary volume ofintake in order to ensure adequate caloric intake to achieve a minimum weight gain of 15¿20 g/day.Nursery staff responsible for stress reduction and avoidance of sleepcycle disruption. 25 Placebo
Experimental Group multi-sensory stimulation program 45min daily 2 successive weeks 1-Tactile stimulation with warm palms, the neonate's body was gently stroked from head followed by the neck then upper extremity then lower extremity then returns back for 10 minutes. 2-Vestibular stimulation: The neonate was placed in a hammock in a supine position and is elevated slowly to a semi- sitting position, after which the infant is lowered back to a supine position. This activity must b 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Their ranged from 32 to 36 weeks of gestation including moderate preterm and late preterm. - Their weight ranged from 1000g to 2000g including LBW and VLBW. - Diagnosed with intraventricular hemorrhage grade I& II, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Kernicterus and None confirmed Sepsis). - Congenital malformation, Chromosomal anomaly and inborn errors of metabolism. - Seizure Disorders. - Chronic medical complications including ( severe pulmonary dysplasia, Interventricular hemorrhage grade III & IV, Periventricular leukomalacia) - Required mechanical life support (ventilation). - Are deemed medically unstable by neonatologist. 1 Day(s) 30 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/02/2018 Research Ethical Committee of Faculty of Physical Therapy ¿ Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayyat Dokki Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome behavioral development (Tone and motor pattern, total behavior response, habituation, state regulation, state organization, reflexes, autonomic system, social interactive and primitive reflexes) - before intervention program - after two weeks of the intervention program
Secondary Outcome Weight gain - before intervention program - after two weeks of the intervention program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Talkha Central Hospital Talkha st. Talkha 35111 Egypt
Mansoura International Specialized Hospital Alsalam St. Mansoura 35111 Egypt
Mansoura Insurance Hospital Sandoub Mansoura 35111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding source Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of Physical Therapy - Cairo University 7 Ahmed El-Zayyat Dokki Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Abdelaziem 7 Ahmed El-Zayyat Dokki Egypt
Mohamed Ali El-Shafey 7 Ahmed El-Zayyat Dokki Egypt
Nehad Nasef 60 Al-Gomhouria Mansoura Egypt
Eman Kamal Abdelmoteleb 7 Ahmed El-Zayyat Dokki Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Abdelaziem faten.hassan@pt.cu.edu.eg +201008554818 7 Ahmed Elzayyat
City Postal code Country Position/Affiliation
Egypt Professor in the department of Physical Therapy for Pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed El shafey elrahmapt@gmail.com +201280232088 7 Ahmed Elzayyat
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Scientific Enquiries Nehad Nasef nehad_nasef@yahoo.com +201001229299 60 Algomhoria
City Postal code Country Position/Affiliation
Mansoura Egypt Professor
REPORTING
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