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Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

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ClinicalTrials.gov Identifier: NCT03726697
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jubara Alallah, King Abdullah International Medical Research Center

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.

Condition or disease Intervention/treatment Phase
Neonatal Hypoglycemia Infant, Small for Gestational Age Macrosomia, Fetal Intrauterine Growth Restriction Premature Infant Neonatal; Hypoglycemia, Diabetes, Maternal Other: Tahneek Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Parents and Statistician are blinded
Primary Purpose: Prevention
Official Title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : May 22, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
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.
Other: 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.



Primary Outcome Measures :
  1. Hypoglycemia [ Time Frame: first 48 hours of life ]
    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.

  2. Admission to NICU for hypoglycemia [ Time Frame: first 48 hours of life ]
    infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.


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

  2. Breastfeeding [ Time Frame: 6 months ]
    will asses the breastfeeding rate in the study infants, compared to controls at discharge from hospital (full or exclusive) and at 6months of age.

  3. Pain scale [ Time Frame: 48 hours ]
    Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay



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Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726697


Locations
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Saudi Arabia
King Abdulaziz Medical City
Jeddah, WR, Saudi Arabia, 21423
Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
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Principal Investigator: Jubara Alallah, MD King Abdullah International Medical Research Center

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Responsible Party: Jubara Alallah, Assistant Professor of Pediatrics, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT03726697     History of Changes
Other Study ID Numbers: KAIMRC
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jubara Alallah, King Abdullah International Medical Research Center:
Tahneek
Neonatal; Hypoglycemia, Diabetes, Maternal
Neonatal Hypoglycemia
late preterm infants
Prevention
IUGR
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Macrosomia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms