FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036785 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Mixed Method 
Study Design  Other 
Public Title of Study   Knowledge, Perception (understanding) and Practices of Parents and Health professionals about Behavioural ( baby’s behaviour) and Physiological cues (parameters of NICU monitor) of Preterm infants (baby born before 37 complete weeks)  
Scientific Title of Study   Knowledge, Perception and Practices of Parents and Health professionals about Behavioural and Physiological cues of Preterm infants 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NlL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Radhika Attal 
Designation  PG Student (MPT Pediatrics) 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916676760  
Fax    
Email  radhika.attal@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhamini Krishna Rao 
Designation  Professor, Department of Physiotherapy (PhD, MPT) 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8660644145  
Fax    
Email  bhamini.kr@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Selvam Ramachandran 
Designation  Associate Professor, Department of Physiotherapy (PhD, MPT) 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9686738297  
Fax    
Email  selvam.ram@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Miss Radhika Attal 
Address  Department of Physiotherapy, Manipal College of Health professions, Manipal Academy of Higher education 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Radhika Attal  Step Down and NICU, Kasturba Hospital  1st floor, Women and Children Block, Department of pediatrics, Kasturba Hospital, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA 		 9916676760

radhika.attal@learner.manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee  Approved 
Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preterm Infants behaviour and physiological cues 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  FOR PARENTS:
• Parents have been given the opportunity to handle the baby for at least 1 week
• Can speak Hindi/ English/ Kannada languages

FOR INFANTS:
• Preterm: 32 weeks to 36 weeks + 6 days gestational age

FOR HEALTH PROFESSIONALS:
• At least 6 months work experience with preterm infants in the NICU 
 
ExclusionCriteria 
Details  FOR PARENTS:
• Parents who had current twin or multiple pregnancy
• Diagnosed depression, on medications

For infants:
• Infants with congenital anomalies/gross neurological damage
• Infants that require sedation or vasoactive drugs
• Infants who have undergone surgery
• Infants receiving palliative care

For Health professions:
NIL 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Score of "Checklist for assessment of knowledge of cues"

2. "Themes" generated from "interviewing" parents and health professionals. 		 1. After recruiting, a "checklist" will be administered.

2. After filling the checklist, all participants will be interviewed. Post finishing all interviews, themes will be generated. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 05/03/2022 
Date of First Enrollment (Global)  01/10/2021 
Date of Study Completion (Global) 05/03/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Title of the project : Knowledge, Perception and Practices of Parents and Health professionals about Behavioural and Physiological cues of Preterm infants

Background: Parents and health professionals observing or handling the preterm infant in the NICU need to be able to recognize, understand and adapt their care & intervention in accordance with the infant’s behaviour and physiological cues, in order to support the infant’s competencies and to reduce their stress. 

Methodology: Approval was sought from the Institutional Research Committee, MCHP and Institutional Ethics Committee. A separate “Interview guide” and “Checklist for assessment of knowledge of cues” for parents and health professionals was prepared in Kannada (for parents) and English (for parents and health professionals). The interview guide was improvised based on corrections by Physiotherapists expert in Pediatrics and experts in Qualitative research.  “Checklist for assessment of knowledge of cues” was validated by a panel of experts and translate to Hindi and Kannada. 

Participants will be screened according to the inclusion & exclusion criteria. Participant information sheet and written informed consent will be obtained from all the participants.
The “knowledge” aspect of our objective would be checked via the "Checklist for assessment of knowledge of cues" followed by an in depth interview of parents of preterm infants and health professionals handling them(audio recorded). The conversation will be transcribed to English.  ATLAS: TI software (thematic inductive approach) will be used for data analysis. The inference from the study will be used to develop guidelines/ framework for developing a video module which can later be used in a future study for developing the video-module which will be validated by a panel of experts (Physiotherapists, Occupational therapists and Speech therapists experts in pediatrics) by keeping the level of agreement between raters > 60% for each guideline.
 
Close