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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Parents and Statistician are blinded|
|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|
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.
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.
- 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.
- 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
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
|King Abdulaziz Medical City|
|Jeddah, WR, Saudi Arabia, 21423|
|Principal Investigator:||Jubara Alallah, MD||King Abdullah International Medical Research Center|