| CTRI Number |
CTRI/2017/11/010645 [Registered on: 27/11/2017] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [40% dextrose gel application over buccal mucosa] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of low blood sugar by 40% Oral Dextrose gel in newborn infant of diabetic
mother |
|
Scientific Title of Study
|
Role of 40% oral dextrose gel on prevention of hypoglycemia in newborn Infants of Diabetic Mother (IDM) – A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thanigainathan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9176078520 |
| Fax |
|
| Email |
thanigaipaeds@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thanigainathan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9176078520 |
| Fax |
|
| Email |
thanigaipaeds@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Thanigainathan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Assistant Professor, Neonatology Department, Christian Medical College, Vellore, Tamil nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9176078520 |
| Fax |
|
| Email |
thanigaipaeds@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Vellore, India. |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Vellore, Tamilnadu, Vellore. |
| 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 |
| Sivam Thanigainathan |
Christian Medical College |
Department of Neonatology, Christian Medical College, Vellore.
Vellore
TAMIL NADU |
9176078520
thanigaipaeds@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College Ethical committee,vellore, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infant of diabetic mother more than 35 weeks of gestational age and more than 2 kg., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
40% dextrose gel |
1.Strict thermoregulation in delivery room (NRP recommendation)
2.Apply oral dextrose gel 200mg/kg over buccal mucosa
3.Start Direct breast feeding (within 30 mins)
4.Every feed should be not less than 20 minutes
5.First GRBS measurement at one and half an hour
6.Continue Direct breast feed (DBF) Q2-3Hourly
7.If baby not suck at breast 5 ml/kg of expressed colostrum will be given to term babies (If colostrum not available, 2:1 will be given) and 3.5 ml/kg of expressed colostrum will be given to preterm babies.
8.Monitor temperature at 1 hour of life followed by 6th hourly. |
| Comparator Agent |
No dextrose gel |
1.Strict thermoregulation in delivery room (NRP recommendation)
2.Start Direct breast feeding (within 30 mins)
3.Every feed should be not less than 20 minutes
4.First GRBS measurement at one and half an hour
5.Continue Direct breast feed (DBF) Q2-3Hourly
6.If baby not suck at breast 5 ml/kg of expressed colostrum will be given to term babies (If colostrum not available, 2:1 will be given) and 3.5 ml/kg of expressed colostrum will be given to preterm babies.
7.Monitor temperature at 1 hour of life followed by 6th hourly. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Infant of diabetic mother more than 35 weeks of gestational age and more than 2 kg. |
|
| ExclusionCriteria |
| Details |
1. Requiring admission before randomization (preterm neonates less the 35 weeks of gestational age, birth weight less than 2000 grams, respiratory distress, major lethal congenital malformation, antenatal ultrasound findings with absent/reversal of end diastolic mesenteric flow, Rh negative mother with DCT positive baby and indication suggested by consultants).
2. No consent
3. Major congenital malformation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypoglycemia |
in the first 24 hours after birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in admission rate due to hypoglycemia
|
in the first 24 hours after birth |
Formulation of scoring system to predict the responder and non-responder to oral dextrose gel based on following risk factors:
Type of maternal diabetes
Uncontrolled maternal diabetes
Placentomegaly
cord blood glucose
cord blood C peptide level
rate of fall of blood glucose at one and half an hour
SGA
LGA
macrosomia
IUGR
prematurity
low birth weight
PIH
maternal use of beta blocker and dextrose containing IV fluids during labor
cold stress
hypothermia |
one and half an hour of life |
| Duration of hospital stay |
within 28 days of life |
| Maximum requirement of Glucose Infusion Rate |
till 24 hours of life |
| Incidence of rebound hypoglycemia |
till 24 hours of life |
| Incidence of hyperglycemia |
till 24 hours of life |
| Incidence of late hypoglycemia |
till 24 hours of life |
Rate of exclusive breast feeding till discharge determined by parental
Questionnaire |
till discharge |
| Incidence of feed intolerance |
till 24 hours of life |
| Incidence of Necrotizing Enterocolitis |
till 24 hours of life |
| Incidence of sepsis without antenatal risk of sepsis |
till discharge |
| Number Needed to Treat |
till 24 hours of life |
| Compliance of care |
till 24 hours of life |
| Maternal satisfaction |
till discharge |
| Onset of action and duration of action of oral dextrose gel |
till 24 hours of life |
| Rate of rise of glucose due to oral dextrose gel |
till 24 hours of life |
| Rate of exclusive breast feeding up to 6 months of age |
6 months of life |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "611"
Final Enrollment numbers achieved (India)="611" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
23/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Infant of diabetic mother babies are more prone for hypoglycemia. Hypoglycemia causes neonatal morbidity and mortality. Few simple and low cost strategies such as early breast feeding, prolonged breast feeding for more than 20 minutes, frequent feeding every 2-3 hourly and strict thermoregulation in delivery room were studied and found that those interventions decrease the incidence of hypoglycemia in infant of diabetic mother babies and were accepted as standard of care. Recent research with 40% oral dextrose gel also had given promising results in reduction of incidence of hypoglycemia in at risk babies (IDM+SGA+preterm>35 weeks). We planned to study the add on beneficial effect of oral dextrose gel on prevention of hypoglycemia in infant of diabetic mother. We plan a study with the aim of, "To study the prophylactic effect of 40% oral dextrose gel on prevention of neonatal hypoglycemia in infants of diabetic mother and to formulate a scoring system to predict the responder and non responder to 40% oral dextrose gel". All mothers will be conselled for the importance of early, frequent & prolonged colostrum feeding. We will send the cord blood glucose and cord blood marker of high insulin level (C peptide) in Infant of diabetic mother (IDM ) babies. We will apply 200mg/kg of 40% oral dextrose gel within 30 minutes of life in study group followed by breast feeding and only breast feeding without gel in control group. We will measure the blood glucose level in both the groups at 11/2 , 3, 5, 7, 12 , 18, 24 hour of life. We will measure the beneficial action of oral dextrose gel in the form of reduction in incidence of hypoglycemia, requirement of intravenous fluid, admission, not decrease the rate of exclusive breast feeding without causing any harm effect like hyperglycemia, late hypoglycemia and rebound hypoglycemia. We will try to formulate a scoring system to predict the responder and non responder to oral dextrose gel. Also we will find out few pharmacokinetic properties of 40% oral dextrose gel like onset of action, duration of action and rate of rise of blood glucose. |