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CTRI Number  CTRI/2024/01/062059 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Optimal care for pre-term and low birthweight infants: A Pilot Study 
Scientific Title of Study   Piloting and refinement of an in-facility supportive care package for optimal feeding and preventive-promotive care of low birthweight and preterm infants admitted to level-2 neonatal intensive care units 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarti Kumar 
Designation  CEO and Principal Scientist 
Affiliation  Community Empowerment Lab 
Address  Community Empowerment Lab Address: A-6/14, Vineet Khand 6, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  919936060008  
Fax    
Email  aarti.kumar@celworld.org  
 
Details of Contact Person
Scientific Query  
Name  Aarti Kumar 
Designation  CEO and Principal Scientist 
Affiliation  Community Empowerment Lab 
Address  Community Empowerment Lab Address: A-6/14, Vineet Khand 6, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  919936060008  
Fax    
Email  aarti.kumar@celworld.org  
 
Details of Contact Person
Public Query  
Name  Vinay Pratap Singh 
Designation  Director Research Mangement 
Affiliation  Community Empowerment Lab 
Address  Community Empowerment Lab Address: A-6/14, Vineet Khand 6, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  919818000252  
Fax    
Email  vinaypratap.singh@celworld.org  
 
Source of Monetary or Material Support  
Community Empowerment Lab,F-09, 9th Floor, F-Block, Tower-B, Shalimar Grand, 10 Jopling Road, Lucknow - 226001 (India)  
 
Primary Sponsor  
Name  Community Empowerment Lab 
Address  F-09, 9th Floor, F-Block, Tower-B, Shalimar Grand, 10 Jopling Road, Lucknow - 226001 (India) 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aarti Kumar  Community Empowerment Lab  A-6 14, Vineet Khand 6, Gomti Nagar, 226010
Lucknow
UTTAR PRADESH 		 9936060009

aarti.kumar@celworld.org 
Dr Arun Kumar Arya  Ganesh Shankar Vidyarthi Memorial Medical College  Department of Paediatrics, 1st Floor, HOD Room, Hallet Hospital under GSVM Medical College, Swaroop Nagar 208002
Kanpur Nagar
UTTAR PRADESH 		 9451425801

arunped253@yahoo.com 
Dr Ashok Kumar  Institute of Medical Sciences Banaras Hindu University  IMS, Banaras Hindu University, Department of Paediatrics, 3rd Floor, Aurobindo Colony, Bhelupur 221005
Varanasi
UTTAR PRADESH 		 9415300370

ashokkumar_bhu@hotmail.com 
Dr Mala Kumar  King George’s Medical University  Department of Paediatrics, Ground Floor, HOD Room, King Georges Medical University, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 9415470555

malakumar@kgmcindia.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Banaras Hindu University Institutional Ethics Committee  Approved 
Community Empowerment Lab Institutional Ethics Committee  Approved 
Ethics Committee, GSVM Medical College Kanpur  Approved 
Institutional Ethics Committee KGMU Lucknow  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  27.00 Day(s)
Gender  Both 
Details  1. LBW (less than 2.5 kg) or preterm (less than 37 weeks) infants admitted in the NICU of the study facility.
2. In-born infants admitted to the NICU within 24 hours of birth
3. Mother and infant alive during screening
4. Mother consents for herself and infant
5. Women (mothers) who are 18+ years of age
6. All clinical study team members to be included with no exclusions.
 
 
ExclusionCriteria 
Details  1. Out-born infants referred to study facility NICU.
2. Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric or orogastric (NG or OG) tube [e.g., cleft lip or palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, NEC]
3. Severe birth asphyxia
4. Unknown date of birth and or unknown gestational age 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Mean timing baby first fed mother breast milk post-birth
2. Mean time to mother first breast stimulation via first breast milk expression or baby first put to breast
3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours
4. Mean number of breast milk expression sessions in the last 24 hours
5. Maternal self-efficacy or confidence (different tools for those who expressed and those who fed directly at the breast) 		 Daily till the discharge of newborn or 14 days after admission whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean timing of baby first fed mother breast milk post-NICU admission
2. Management of feeding difficulties
3. Percentage receiving at least 8 hours of KMC in last 24 hours)
4. Any KMC in last 24 hours
5. Percentage Infant fed exclusive MOM in the last 24 hours
6. Mean weight velocity (growth) (g per kg per day) 		 Daily or till the discharge of newborn or 14 days after admission 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="25" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aarti.kumar@celworld.org].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-11-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Numerous curricula and guidelines encompass elements of crucial principles related to lactation support, Kangaroo Mother Care (KMC), and Water, Sanitation, and Hygiene (WASH). However, a significant gap exists in the form of a comprehensive package that integrates all essential components of preventive-promotive care. This care is intended to be delivered by health providers to both newborns and mothers, ensuring optimal health and growth outcomes for small and vulnerable infants. As part of a global initiative, PATH, in collaboration with USAID, is actively developing a package focused on Specialized Lactation Support and Newborn Nutrition for Small and Sick Newborns. This effort includes the creation of a training curriculum, guide, Standard Operating Procedures (SOPs), and job aids.

The package is designed to build upon existing curricula, filling gaps in newborn feeding and lactation management. Additionally, elements of Kangaroo Mother Care (KMC) and Water, Sanitation, and Hygiene (WASH) are being incorporated to form the comprehensive "in-facility feeding support plus package." A co-design workshop, engaging key stakeholders such as obstetricians, pediatricians, and nursing teams, was conducted in partnership with Ariadne Labs and PATH. The workshop aimed to understand existing guidelines, care workflows, identify gaps, and determine needs. The insights from this workshop are being integrated into the development of the "in-facility feeding support plus" package. The primary objective of this study is to pilot the developed "in-facility feeding support plus" package, utilizing skilled study nurses. The rigorous evaluation will focus on assessing the impact of the ideal delivery of the package on newborn feeding, KMC and WASH practices, infant growth, and maternal self-efficacy. These outcomes will be compared against a baseline.

Additionally, the study will evaluate the acceptability and feasibility of the package itself. The data collected will be systematically analyzed and shared with the Ariadne Labs team to refine the package for deployment in an implementation setting. The goal is to create a globally harmonized package with universal elements for use across countries and sites, incorporating locally contextualized and adapted elements applicable to Uttar Pradesh (UP) and India.
 
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