Clinical trial NCT03726697: Effect of Tahneek on Hypoglycemia in Newborn Infants
Official title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hypoglycemia
Infant, Small for Gestational Age
Macrosomia, Fetal
Intrauterine Growth Restriction
Premature Infant
Neonatal; Hypoglycemia, Diabetes, Maternal
Keywords: Tahneek
Neonatal; Hypoglycemia, Diabetes, Maternal
Neonatal Hypoglycemia
late preterm infants
Prevention
IUGR
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 324
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Hypoglycemia
timeFrame: first 48 hours of life
measure: Admission to NICU for hypoglycemia
timeFrame: first 48 hours of life
Secondary outcomes:
measure: Hyperglycemia
timeFrame: 48 hours
measure: Breastfeeding
timeFrame: 6 months
measure: Pain scale
timeFrame: 48 hours
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City
state: WR
Study officials:
affiliation: King Abdullah International Medical Research Center
name: Jubara Alallah, MD
role: PRINCIPAL_INVESTIGATOR
References: