Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction; Premature Infant; Infant, Small for Gestational Age; Neonatal Hypoglycemia; Macrosomia, Fetal; Neonatal; Hypoglycemia, Diabetes, Maternal
• Intervention / Treatment: Other: Tahneek

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: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • WR
    • Jeddah, WR, Saudi Arabia, 21423
      • King Abdulaziz Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL; Infants at risk for transient neonatal hypoglycemia following standard-of-care.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours
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.	6 months
Pain scale	Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay	48 hours

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Jubara Alallah, MD, King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 22, 2019
• Study Completion (Actual): May 22, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Prevention; IUGR; Tahneek; Neonatal; Hypoglycemia, Diabetes, Maternal; Neonatal Hypoglycemia; late preterm infants
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Growth Disorders; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Hypoglycemia; Fetal Growth Retardation; Fetal Macrosomia
• Other Study ID Numbers: KAIMRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No