Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

King Abdullah International Medical Research Center

Status: Completed

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

Treatments: Other: Tahneek

Study type: Interventional

Funder types: Other

Identifiers

NCT03726697

KAIMRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 patients

Sex: All

Ages: Under 1 hour old

Volunteers: No 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)

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 2 patient groups

Tahneek

Experimental group

Description:

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.

Treatment:

Other: Tahneek

CONTROL

No Intervention group

Description:

Infants at risk for transient neonatal hypoglycemia following standard-of-care.