Effect of Tahneek on Hypoglycemia in Newborn Infants

NCT03726697 | Completed DMC

• 1 other identifier: KAIMRC
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Hyperglycemia

  48 hours

• Breastfeeding

  6 months

• Pain scale

  48 hours

Study Arms (2)

Tahneek

EXPERIMENTAL

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

CONTROL

NO INTERVENTION

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

Interventions

Tahneek OTHER

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

Tahneek

Eligibility Criteria

• Age: Up to 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King Abdulaziz Medical City

Jeddah, WR, 21423, Saudi Arabia

Location

MeSH Terms

Conditions

Fetal Macrosomia; Fetal Growth Retardation; Premature Birth; Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Growth Disorders; Pathologic Processes; Obstetric Labor, Premature; Obstetric Labor Complications; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jubara Alallah, MD

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Parents and Statistician are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: November 1, 2018
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

SA (1)