| CTRI Number |
CTRI/2018/04/013096 [Registered on: 06/04/2018] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educating new mothers after delivery on Essential Newborn Care and studying the growth and Iron Status of her infant till 6 months |
|
Scientific Title of Study
|
Post-Delivery Re-inforcement of Education on Essential newborn care in Malnourished Primigravidae and Assessment of Impact on Growth and Iron Status in Infants till 6 months:A Single Blinded Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1201-9697 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College,Mangaluru |
| Address |
Lighthouse Area,
Hampankatta
Mangaluru,
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08789305854 |
| Fax |
|
| Email |
nehamauve@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College,Mangaluru |
| Address |
Department of Pediatrics,
Lighthouse Area,
Hampankatta,
Mangaluru,
Karnataka.
575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448147687 |
| Fax |
|
| Email |
nutan.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College,Mangaluru |
| Address |
Lighthouse Area,
Hampankatta
Mangaluru,
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08789305854 |
| Fax |
|
| Email |
nehamauve@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Neha,
Department of Pediatrics,
Hampankatta,Near Light House Area,
KMC Mangaluru 575001 |
|
|
Primary Sponsor
|
| Name |
Neha |
| Address |
Department of Pediatrics,
Hampankatta,Near Light House Area,
KMC Mangaluru 575001 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Neha |
Lady Goschen Hospital |
Obstetrics and Gynaecology Department,Maidan Road,
Hampankatta,
Mangaluru
Dakshina Kannada
KARNATAKA |
08789305854
nehamauve@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The patients are healthy human vounteers from community with weight of less than 45 kgs durinf conception.At the time of recruitment,they had no other life threatening conditions as explained in the exclusion criteria. |
| Patients |
1)Malnourished Primigravidae with Pre-Pregnancy weight or first documented weight less than 45 kg
2)Their babies , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Existing IEC |
Information abut essential newborn care from AWW,ANM and ASHA,mother,mother in law and other members of society |
| Intervention |
Flipcharts Demonstrations |
Re-inforcing the existing IEC system regarding Essential newborn care by flipcharts and demonstrations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Primigravidae mothers
Singleton Pregnancy
Pre-Pregnancy weight or First Documented Weight less than 45 kg |
|
| ExclusionCriteria |
| Details |
1.Gravida with life threatening conditions(Pre-eclampsia and eclampsia, uncontrolled blood sugar with HbA1C >6.5%,Uncompensated cardiovascular diseases with NYHA Grade 3 and above)
2.Neonates with gross congenital anomalies
3.Neonates with NICU stay
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Infant’s weight gain and growth velocity plotted against WHO growth standards.
Status of iron levels in mothers and their newborns.
|
0,6,10,14 weeks and 6 months for the baby.
at birth for mother.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Total duration of exclusive breast feeding .
Hygiene practices.
Recognition of danger signs.
Frequency of illness in the infant.
Percentage of Retention of knowledge about essential newborn care by mothers.
|
6th month |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
31/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The subset analysis is published under the title " Influencing variables for fetal growth in malnourished mothers:A nested Case-Control Study"in Clinical Epidemiology and Global Health,December 2019 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Every year .75 million neonates die in India which is highest in the world.The concept of essential newborn care implies how short and simple interventions can provide both immediate and long term benefits in these babies. The concept of Essential Newborn Car given by WHO includes: 1)cleanliness of cord and delivery 2)Thermal protection 3)Early and exclusive breastfeeding 4)Initiation of breastfeeding and resuscitation 5)Eye care 6)Immunization 7)Management of newborn illnesses 8)Care of preterms and Low Birth Weight Infants Study group will be selected upon satisfying both inclusion and exclusion criteria.Study participants will be approached in the ward they are admitted .The nature and objectives of study to be explained to them in a language they comprehend.A written informed consent will be obtained from them.After that a pre-tested questionnaire will be administered to the study participants.Using simple random sampling and block randomization,the study subjects will be divided in intervention group and those receiving standard care. The intervention group will receive re-inforcement of the ENC knowledge by a trained MSW worker while the standard group will recieve knowledge by existing IEC system. The outcome will be measured in terms of increase in weight and growth velocity measured at 0,6,10,14 weeks and 6 months.Ferritin levels will be measured of the mother during the perinatal period and of the baby at birth(cord blood) and at 6 months. The attempt to assess the knowledge of malnourished mothers will help to identify the lacunae for improvement in the existing system and by re-inforcing the ENC knowledge through flip charts and demonstrations,a better outcome can be obtained in terms of infant growth velocity and weight. Assessment of ferritin levels at birth and at 6 months will help to identify early iron deficiency and subsequent treatment can be given.
Conclusion: Mothers who were formally trained with flip charts and practice session had better retention
of ENC knowledge. The peripartum period was a receptive time for the mother. Educating
her to take care of the baby helped in achieving better infant growth. The babies who were
exclusively breast fed have lower ferritin, however it was not statistically significant. The
growth of the baby was not related to the maternal and foetal iron stores.
|