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CTRI Number  CTRI/2026/02/104256 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   QUASI EXPERIMENTAL STUDY 
Study Design  Other 
Public Title of Study   Feeding based on babys cues in preterm infants and its imapact on their growth and early brain development 
Scientific Title of Study   Cue-Based Feeding in Preterm Infants With Short Term Growth And Neurodevelopmental outcome:A Quasiexperimental Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meghana K 
Designation  MD Paediatrics resident 
Affiliation  KLE Academy of Higher Education and Research 
Address  KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College Department of Paediatrics

Belgaum
KARNATAKA
590010
India 
Phone  9742641376  
Fax    
Email  kmeghana100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa Bellad 
Designation  Professor 
Affiliation  JNMC 
Address  Department of paediatrics ,JNMC

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  roopabellad@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meghana K 
Designation  MD Paediatrics resident 
Affiliation  KLE Academy of Higher Education and Research 
Address  KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College Department of Paediatrics

Belgaum
KARNATAKA
590010
India 
Phone  9742641376  
Fax    
Email  kmeghana100@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College  
 
Primary Sponsor  
Name  DR.Meghana K 
Address  DEPARTMENT OF PAEDIATRICS, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, JNMEDICAL COLLEGE, BELAGAVI-590010 Mobile Number-9742641376 
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 
DR MEGHANA K  KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, JN MEDICAL COLLEGE, BELAGAVI.
Belgaum
KARNATAKA 		 9742641376

kmeghana100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy babies  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARATOR GROUP  ALREADY ATTAINED NORMAL FEEDING 
Intervention  INTERVENTION GROUP  CUE BASED FEEDING 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  90.00 Month(s)
Gender  Both 
Details  1.Who have attained corrected gestation age of 32 weeks or more

2.Have attained complete oral feeding (paladai feeding) for 24hrs
3. Discontinued all parenteral fluids 
 
ExclusionCriteria 
Details  a) Pretern neonate with congenital malformation
b)Preterm neonate with chromosomal abnormality
c)Preterm nenate with gastrointestinal surgical interventions
d)Lack of weight gain for 3 consecutive days after inclusion in study
e)Feeding prescribed as per physician discretion
e)Preterm neonates treated for Necrotizing enterocolitis, feeding intolerance 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the rate of growth in preterm infants (born less than 37
weeks) who received cue based feeding in NICU and after discharge till 40 weeks of
gestation to that of who has received scheduled feeding in the past 		 To compare the rate of growth in preterm infants (born less than 37
weeks) who received cue based feeding in NICU and after discharge till 40 weeks of
gestation to that of who has received scheduled feeding in the past

and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study duration from onset of full oral feeding to discharge
2. To compare the neurodevelopmental outcome using HNNE score at
40 weeks & HINE score at 3-4 months of corrected age between interventional and
control groups 		 at 40 weeks
and 3 months 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Preterm infants need to be able to coordinate sucking, swallowing, and breathing, sustain alert
awake behavior and preserve cardiorespiratory stability to achieve successful oral feeding  . This
develops through a gradual oral motor maturation process that correlates with the emergence
of motor pathways and maturation of the central nervous system, which correlates with the
postmenstrual age (PMA) of the infant . Until these levels of behavioral readiness and oral
motor maturation are reached, preterm infants commonly require gavage feedings which are
given on a schedule to ensure that specific feeding volumes are consumed. Premature infants
often struggle with oral feeding due to underdeveloped skills and immature neurological
systems  . Traditionally, oral feedings in the NICU are based on fixed schedules and volumes,
rather than the infant’s readiness and ability  . This approach can lead to feeding difficulties,
longer hospital stays, and stress for both infants and caregivers.
Cue-based feeding is a more individualized method that focuses on an infant’s behavioral cues

to determine feeding times and amounts . Behavioral cue-based feeding (BCBF) based on close
observation of the infant’s behavioral signals is a method in which caregivers determine how
and when and how much an infant expects to be fed. Each infant is considered an individual
with meaningful behaviors. A gestational age and volume driven approach to feeding therefore
is shifted towards an infant-driven approach  .These cues include signs of hunger, readiness to
suck, and the ability to coordinate sucking, swallowing, and breathing.
Standardized feeding cues
1. Crying
2. Quiet alert
3. Hand-to-mouth activity
4. Sucking on fingers, fist, or pacifier
5. Rooting
6. Inability to settle after position change, diaper change,
or pacifier
Research suggests that cue-based feeding can support safer, more effective feeding
experiences, promote earlier feeding milestones, and possibly reduce the length of hospital
stays.
The benefits of cue-based oral feeding highlights the need for a shift from volume-driven to
infant-driven feeding practices, aligning with developmental care principles  . By recognizing and
responding to each infant’s cues, caregivers can support better feeding outcomes and overall
development  .
 
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