| CTRI Number |
CTRI/2024/03/064398 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Saline enema] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enema to reduce feed intolerance |
|
Scientific Title of Study
|
Saline Enema versus No Enema to Promote
Enteral Feeding in Preterm Infants:
A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjesh J |
| Designation |
DNB resident |
| Affiliation |
Apollo BGS Hospital |
| Address |
Department of pediatrics
Apollo BGS Hospital,
Adichunchanagiri Road, Jayanagar, Kuvempu Nagara, Mysuru, Karnataka 570023
Mysore
KARNATAKA
570023
India |
| Phone |
9483996475 |
| Fax |
|
| Email |
manjesh2310j@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Girish G |
| Designation |
Consultant Neonatologist |
| Affiliation |
Apollo BGS hospital |
| Address |
Consultant pediatrician and neonatologist,
Apollo BGS Hospital,
Adichunchanagiri Road, Jayanagar, Kuvempu Nagara, Mysuru, Karnataka 570023
Mysore
KARNATAKA
570023
India |
| Phone |
9880185706 |
| Fax |
|
| Email |
drgirishg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Girish G |
| Designation |
Consultant Neonatologist |
| Affiliation |
Apollo BGS hospital |
| Address |
Consultant pediatrician and neonatologist,
Apollo BGS Hospital,
Adichunchanagiri Road, Jayanagar, Kuvempu Nagara, Mysuru, Karnataka 570023
Mysore
KARNATAKA
570023
India |
| Phone |
9880185706 |
| Fax |
|
| Email |
drgirishg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Apollo BGS hospital |
| Address |
Apollo BGS Hospital,
Adichunchanagiri Road, Jayanagar, Kuvempu Nagara, Mysuru, Karnataka 570023 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjesh |
Apollo BGS hospital |
Apollo BGS Hospital,
Adichunchanagiri Road, Jayanagar, Kuvempu Nagara, Mysuru, Karnataka 570023
Mysore
KARNATAKA |
9483996475
manjesh2310j@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Comparator Agent |
No enema |
No enema |
| Intervention |
Saline enema |
5ml/kg of saline enema for enema group. Daily once till 130ml/kg feeds achieved. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Preterm with gestational age 28-32 weeks
Admission to NICU with in 24hrs after birth |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine time to full enteral feeds.
|
Time to achieve full feeds. Can vary from patients to patients.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of NICU stay.
Incidence of feed intolerance.
Time to regain birth weight
NEC incidence |
End of study |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
29/03/2024 |
| 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="2"
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
|
Establishment of enteral nutrition is a significant challenge for premature infants in the neonatal intensive care unit. It is mainly due to delayed gastric emptying, uncoordinated forward propulsive mechanism and increased susceptibility of the gastrointestinal neuronal system to noxious stimulus such as sepsis, acidosis or hypoxia leading to disruption in control of peristalsis. This leads to development of feed intolerance and delay in establishing adequate enteral feeds. Various strategies have been tried to improve feed intolerance which include trophic feeds, use of prokinetics, early meconium evacuation. Our study has an objective of comparing the efficacy of saline enema versus no enema for early meconium evacuation in preterm very low birth weight infants on time to achieve full enteral feeds.
|