Effect of Tahneek on Hypoglycemia in Newborn Infants

Study Overview
=================
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.

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

Conditions
-----------------
Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction, Premature Infant, Neonatal; Hypoglycemia, Diabetes, Maternal

Intervention / Treatment
-----------------
* Other: Tahneek


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 1 Hour

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tahneek<br>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<br>* 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<br>|
| No Intervention: CONTROL<br>Infants at risk for transient neonatal hypoglycemia following standard-of-care. | |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tahneek, Neonatal; Hypoglycemia, Diabetes, Maternal, Neonatal Hypoglycemia, late preterm infants, Prevention, IUGR