THIN: Effect of Tahneek on Hypoglycemia in Newborn Infants

Sponsor

King Abdullah International Medical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT03726697

Collaborator

(none)

324

Enrollment

Location

Arms

6.6

Actual Duration (Months)

48.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Nov 1, 2018

Actual Primary Completion Date :

May 22, 2019

Actual Study Completion Date :

May 22, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hypoglycemia [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 [first 48 hours of life]
infants at-risk will be followed to measure NICU admission data and glucose values during hospitalization.

Secondary Outcome Measures

Hyperglycemia [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 [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 [48 hours]
Pain scale as measured by Neonatal intensive pain scale during the first 48 hrs of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Hour

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)