| CTRI Number |
CTRI/2023/11/059743 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
30/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Threshold for nutritional intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare differences in neurological outcome after two different approaches to feeding support in preterm babies with slow growth. |
|
Scientific Title of Study
|
Effect of two different thresholds to initiate nutritional interventions for postnatal growth faltering on neurodevelopmental disability in very preterm infants: a multicenter randomized controlled trial. |
| Trial Acronym |
NeoFINS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishad Plakkal |
| Designation |
Additional Professor and Head, Neonatology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Neonatology,
Women and Childrens Hospital,
JIPMER, Gorimedu,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708577133 |
| Fax |
|
| Email |
nishad.p@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishad Plakkal |
| Designation |
Additional Professor and Head, Neonatology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Neonatology,
Women and Childrens Hospital,
JIPMER, Gorimedu,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708577133 |
| Fax |
|
| Email |
nishad.p@jipmer.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nishad Plakkal |
| Designation |
Additional Professor and Head, Neonatology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Neonatology,
Women and Childrens Hospital,
JIPMER, Gorimedu,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708577133 |
| Fax |
|
| Email |
nishad.p@jipmer.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Indian Council of Medical Research,
V. Ramalingaswami Bhawan, P.O. Box No. 4911,
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sridhar Santhanam |
Christian Medical College, Vellore |
Department of Neonatology,
Christian Medical College,
Ida Scudder Road,
Vellore - 632004
Tamil Nadu, India
Vellore
TAMIL NADU |
9790606567
santhanamsridhar@gmail.com |
| Dr Mangalabharathi Sundaram |
Institute of Obstetrics and Gynaecology, Chennai |
Institute Of Obstetrics And Gynaecology And Government Hospital For Women And Children
Pantheon Rd,
Egmore, Chennai,
Tamil Nadu 600008,
India
Chennai
TAMIL NADU |
9840786836
drmangalabharathi@gmail.com |
| Dr Nishad Plakkal |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Room no. 5, Department of Neonatology,
JIPMER, Dhanwantri Nagar
Gorimedu
Pondicherry
PONDICHERRY |
7708577133
nishad.p@jipmer.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aggressive threshold |
Initiation of nutritional interventions when the postnatal weight z-score drops 1 z-score below the birth z-score. The study is pragmatic, and the exact duration and type of nutritional intervention is allowed to vary across sites. The randomization is stratified by site to account for variability in this and other confounders. |
| Comparator Agent |
Conservative threshold |
Intervening only if the weight z-score drops 1.5 z-score below the birth z-score. The study is pragmatic, and the exact duration and type of nutritional intervention is allowed to vary across sites. The randomization is stratified by site to account for variability in this and other confounders. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Day(s) |
| Age To |
77.00 Day(s) |
| Gender |
Both |
| Details |
1. Birth gestational age <33 completed weeks.
2. Postnatal weight >1 z score below the birth z score between 10 days of age and 36 weeks postmenstrual age
|
|
| ExclusionCriteria |
| Details |
1. Major congenital anomalies or genetic conditions.
2. Infants on comfort care who are not expected to survive.
3. NICU admission after 48 hours of age
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Major neurodevelopmental disability at 18-20 months corrected age, defined as one or more of the following:
1. Bayley-4 standard score less than 70 in Cognitive or Motor or Language domain.
2. Cerebral palsy GMFCS more than class I.
3. Hearing loss requiring hearing aid.
4. Blindness (vision of less than 3/60 in the better eye)
|
18 to 20 months corrected age.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Death before discharge |
First hospital discharge |
| Neonatal death |
28 days |
| Death |
18-20 months |
| Retinopathy of prematurity requiring treatment |
18 months |
| Necrotizing enterocolitis Stage 2 or higher |
First hospital discharge |
| Bronchopulmonary dysplasia |
First hospital discharge |
| Microcephaly |
18-20 months |
| Underweight |
18-20 months |
| Overweight |
18-20 months |
| Hypertension |
18-20 months |
|
|
Target Sample Size
|
Total Sample Size="654"
Sample Size from India="654"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized, parallel-arm trial aims to compare the effect of two weight loss thresholds to initiate interventions for postnatal growth faltering (PGF), on major neurodevelopmental disability at 18-20 months corrected age in very preterm infants born at a gestational age of <33 completed weeks. Enrolment in this RCT is expected to happen at three centres. Research question: In very preterm infants born at a gestational age of <33 completed weeks (Population), is an aggressive strategy of initiation of nutritional interventions when the postnatal weight z-score drops >1 z-score below the birth z-score (Intervention), compared with a conservative approach of only intervening if the weight z-score drops >1.5 z-score below the birth z-score (Comparator) associated with a lower incidence of major neurodevelopmental disability (Outcome) at 18-20 months corrected age (Time)? |