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History of Changes for Study: NCT03726697
Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial (THIN)
Latest version (submitted May 22, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 30, 2018 None (earliest Version on record)
2 October 30, 2018 Outcome Measures, Study Description, Study Identification and Study Status
3 January 21, 2019 Recruitment Status, Study Status and Contacts/Locations
4 May 22, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03726697
Submitted Date:  October 30, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: KAIMRC
Brief Title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial (THIN)
Official Title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: November 1, 2018
Primary Completion: November 1, 2019 [Anticipated]
Study Completion: November 1, 2020 [Anticipated]
First Submitted: October 30, 2018
First Submitted that
Met QC Criteria:
October 30, 2018
First Posted: October 31, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 30, 2018
Last Update Posted: October 31, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: King Abdullah International Medical Research Center
Responsible Party: Principal Investigator
Investigator: Jubara Alallah
Official Title: Assistant Professor of Pediatrics
Affiliation: King Abdullah International Medical Research Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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. Our 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. Our study is using dates to asses its effect on hypoglycemia
Open or close this module Conditions
Conditions: 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 324 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Tahneek
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.
Tahneek
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
No Intervention: CONTROL
Infants at risk for transient neonatal hypoglycemia following standard-of-care.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Hypoglycemia
[ Time Frame: first 48 hours of life ]

any blood glucose concentration < 2.6 mmol/L
2. Admission to NICU for hypoglycemia
[ Time Frame: first 48 hours of life ]

Secondary Outcome Measures:
1. Hyperglycemia
[ Time Frame: 48 hours ]

any blood glucose concentration > 10 mmol/L
2. Breastfeeding
[ Time Frame: 6 months ]

Breastfeeding at discharge from hospital (full or exclusive)
3. Pain scale
[ Time Frame: 48 hours ]

Pain scale as measured by NIES (Neonatal intensive pain scale)
Open or close this module Eligibility
Minimum Age:
Maximum Age: 1 Hour
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Jubara Alallah, MD
Telephone: 966122266666 Ext. 22069
Email: alallahjs@ngha.med.sa
Study Officials: Jubara Alallah, MD
Principal Investigator
King Abdullah International Medical Research Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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