Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Hypoglycemia [ Time Frame: first 48 hours of life ]
    any blood glucose concentration < 2.6 mmol/L
  • Admission to NICU for hypoglycemia [ Time Frame: first 48 hours of life ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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.
  • 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.
  • Pain scale [ Time Frame: 48 hours ]
    Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Hyperglycemia [ Time Frame: 48 hours ]
    any blood glucose concentration > 10 mmol/L
  • Breastfeeding [ Time Frame: 6 months ]
    Breastfeeding at discharge from hospital (full or exclusive)
  • Pain scale [ Time Frame: 48 hours ]
    Pain scale as measured by NIES (Neonatal intensive pain scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tahneek on Hypoglycemia in Newborn Infants
Official Title  ICMJE Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Parents and Statistician are blinded
Primary Purpose: Prevention
Condition  ICMJE
  • Neonatal Hypoglycemia
  • Infant, Small for Gestational Age
  • Macrosomia, Fetal
  • Intrauterine Growth Restriction
  • Premature Infant
  • Neonatal; Hypoglycemia, Diabetes, Maternal
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Tahneek
  • No Intervention: CONTROL
    Infants at risk for transient neonatal hypoglycemia following standard-of-care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
324
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 22, 2019
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Hour   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726697
Other Study ID Numbers  ICMJE KAIMRC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jubara Alallah, King Abdullah International Medical Research Center
Study Sponsor  ICMJE King Abdullah International Medical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jubara Alallah, MD King Abdullah International Medical Research Center
PRS Account King Abdullah International Medical Research Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP