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Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

Primary Purpose

Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Tahneek
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Hypoglycemia focused on measuring Tahneek, Neonatal; Hypoglycemia, Diabetes, Maternal, Neonatal Hypoglycemia, late preterm infants, Prevention, IUGR

Eligibility Criteria

undefined - 1 Hour (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery.
  • Infants of diabetic mothers (any type of diabetes)
  • Late Preterms (34 - 37 weeks' gestation)
  • Low birth weight (< 2.5 kg ) or Small for gestational age
  • Large for gestational age (> 4 kg or > 90th centile on Fenton's growth chart)

Exclusion Criteria:

  • Major congenital abnormality including severe cleft lip and palate.
  • Babies requiring NICU admission immediately after birth
  • Babies less than 34 weeks of age.
  • Babies whose parents refused to consent

Sites / Locations

  • King Abdulaziz Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tahneek

CONTROL

Arm Description

Infants receiving a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg at 1 hour after birth in the nursery.

Infants at risk for transient neonatal hypoglycemia following standard-of-care.

Outcomes

Primary Outcome Measures

Hypoglycemia
infants who meet eligibility criteria and parents have consented will receive a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg within 1 h after birth. Assess glucose level after 1 feed compared to controls with similar risk factors who are not received Tahneek. hypoglycemia defined as any blood glucose concentration < 2.6 mmol/L.
Admission to NICU for hypoglycemia
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.

Secondary Outcome Measures

Hyperglycemia
infants at-risk who received Tahneek will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization. hyperglycemia defined as any blood glucose concentration > 10 mmol/L.
Breastfeeding
will asses the breastfeeding rate in the study infants, compared to controls at discharge from hospital (full or exclusive) and at 6months of age.
Pain scale
Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay

Full Information

First Posted
October 30, 2018
Last Updated
May 22, 2019
Sponsor
King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03726697
Brief Title
Effect of Tahneek on Hypoglycemia in Newborn Infants
Acronym
THIN
Official Title
Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 22, 2019 (Actual)
Study Completion Date
May 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdullah International Medical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % of normal newborn babies will have low blood glucose concentrations. It has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of NICU admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.
Detailed Description
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. It is a noble practice in Islam, with which the newborn is greeted upon entering into life, usually before milk feeds. It is done by rubbing a softened date on the palate of the new-born just after the birth. The tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. Neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. Treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of NICU admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction, Premature Infant, Neonatal; Hypoglycemia, Diabetes, Maternal
Keywords
Tahneek, Neonatal; Hypoglycemia, Diabetes, Maternal, Neonatal Hypoglycemia, late preterm infants, Prevention, IUGR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Parents and Statistician are blinded
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tahneek
Arm Type
Experimental
Arm Description
Infants receiving a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg at 1 hour after birth in the nursery.
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Infants at risk for transient neonatal hypoglycemia following standard-of-care.
Intervention Type
Other
Intervention Name(s)
Tahneek
Intervention Description
A single dose of soft date containing glucose equivalent to 200mg/kg at 1 h after birth will be massaged into the buccal mucosa of the palate and cheek from right to left side, until the date paste is fully absorbed
Primary Outcome Measure Information:
Title
Hypoglycemia
Description
infants who meet eligibility criteria and parents have consented will receive a single dose of soft date, prepacked by the pharmacy containing glucose equivalent to 200mg/kg within 1 h after birth. Assess glucose level after 1 feed compared to controls with similar risk factors who are not received Tahneek. hypoglycemia defined as any blood glucose concentration < 2.6 mmol/L.
Time Frame
first 48 hours of life
Title
Admission to NICU for hypoglycemia
Description
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.
Time Frame
first 48 hours of life
Secondary Outcome Measure Information:
Title
Hyperglycemia
Description
infants at-risk who received Tahneek will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization. hyperglycemia defined as any blood glucose concentration > 10 mmol/L.
Time Frame
48 hours
Title
Breastfeeding
Description
will asses the breastfeeding rate in the study infants, compared to controls at discharge from hospital (full or exclusive) and at 6months of age.
Time Frame
6 months
Title
Pain scale
Description
Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay
Time Frame
48 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery. Infants of diabetic mothers (any type of diabetes) Late Preterms (34 - 37 weeks' gestation) Low birth weight (< 2.5 kg ) or Small for gestational age Large for gestational age (> 4 kg or > 90th centile on Fenton's growth chart) Exclusion Criteria: Major congenital abnormality including severe cleft lip and palate. Babies requiring NICU admission immediately after birth Babies less than 34 weeks of age. Babies whose parents refused to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jubara Alallah, MD
Organizational Affiliation
King Abdullah International Medical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdulaziz Medical City
City
Jeddah
State/Province
WR
ZIP/Postal Code
21423
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Tahneek on Hypoglycemia in Newborn Infants

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