| CTRI Number |
CTRI/2014/07/004720 [Registered on: 08/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/06/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of stimulation ( by stroking babies cheeks, chin, lips, tongue and gum)on spoon feed and breast feed initiation. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of Oro motor stimulation along with routine care in terms of feeding performance in preterm babies admitted in neonatal unit (NNN and NICU), Nehru Hospital, 2013-14. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Bala |
| Designation |
M.Sc.Nursing student |
| Affiliation |
National institute of nursing education |
| Address |
final year m.sc.student,Natioanl institute of nursing education,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815703415 |
| Fax |
|
| Email |
bpoonam21@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupinder Kaur |
| Designation |
Clinical Instructor |
| Affiliation |
National institute of nursing education |
| Address |
NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
kauramanjot40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Bala |
| Designation |
M.Sc.Nursing Student |
| Affiliation |
National Institute of Nursing Education |
| Address |
FINAL YEAR M. SC. NURSING STUDENT,
NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815703415 |
| Fax |
|
| Email |
bpoonam21@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
sector-12,postgraduate institute of research and education, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| poonam bala |
neonatal unit ,nehru hospital, PGIMER |
NICU,Neonatal nursery,Nehru hospital,PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9815703415
bpoonam21@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hemodynamically,neurologically stable preterm neonates and in transition time from tube feed to oral feeds, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-nutritive sucking |
It is sucking activity without the ingestion of nutrients |
| Intervention |
Oro-motor stimulation along with routine care i.e. non-nutritive sucking |
Oro-motor stimulation is perioral and intraoral stoking/stimulation with index finger by trained mother of neonate. Duration of stimulation was 4 minutes,5 times daily before every feed till discharge of baby.
Non-nutritive sucking is sucking activity without the ingestion of nutrients. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
8.50 Day(s) |
| Gender |
Both |
| Details |
1. Preterm neonates of gestational age 28-34 weeks
2. Babies who are in transition from tube to oral feeds
3. Babies free of apnea,not in shock,not on CPAP/Ventilator
4. Babies getting Non-nutritive sucking and KMC as routine care
|
|
| ExclusionCriteria |
| Details |
1. Babies having respiratory distress.
2. On CPAP/Ventilator
3. Hemo-dynamically unstable babies
4. Neonates having congenital malformations.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| feeding efficacy of preterm babies,suck pattern improvement,feed ingestion rate |
feeding efficacy of preterm babies,suck pattern improvement,feed ingestion rate were assessed first at enrollment and after that every 5th day till dicharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| transition time to reach spoon feed, breast feed |
till discharge of patient |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this is a randomized control trial to assess the effect of oromotor stimulation along with routine care (non-nutritive sucking,KMC) on the feeding performance of preterm neonates admitted in the neonatal unit of nehru hospital PGIMER chandigarh.the patients were assessed for inclusion criteria and assigned to two groups(control and intervention group) randomly.one group was given routine care only and intervention or experimental group was given oromotor stimulation in addition to routine care. outcomes like sucking pattern , spoon feed ingestion rate , feeding mode were assessed every 5th day in both the groups.neonates in both groups were observed and followed till their discharge. at discharge the transition time to reach spoon feed and breast feed was noted and compared. both the groups were compared for their feeding efficacy improvement on the basis of all mentioned variables |