Effect of Tahneek on Hypoglycemia in Newborn Infants (THIN)

• ClinicalTrials.gov Identifier: NCT03726697
• Recruitment Status: Completed
• First Posted: October 31, 2018
• Last Update Posted: May 23, 2019
• Sponsor: King Abdullah International Medical Research Center
• Information provided by (Responsible Party): Jubara Alallah, King Abdullah International Medical Research Center

Tracking Information

• First Submitted Date: October 30, 2018
• First Posted Date: October 31, 2018
• Last Update Posted Date: May 23, 2019
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: May 22, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2018)

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

Original Primary Outcome Measures (submitted: October 30, 2018)

• Hypoglycemia [ Time Frame: first 48 hours of life ]
  any blood glucose concentration < 2.6 mmol/L
• Admission to NICU for hypoglycemia [ Time Frame: first 48 hours of life ]

Current Secondary Outcome Measures (submitted: October 30, 2018)

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

Original Secondary Outcome Measures (submitted: October 30, 2018)

• Hyperglycemia [ Time Frame: 48 hours ]
  any blood glucose concentration > 10 mmol/L
• Breastfeeding [ Time Frame: 6 months ]
  Breastfeeding at discharge from hospital (full or exclusive)
• Pain scale [ Time Frame: 48 hours ]
  Pain scale as measured by NIES (Neonatal intensive pain scale)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Tahneek on Hypoglycemia in Newborn Infants
• Official Title: Effect of Tahneek With Dates on Hypoglycemia in Newborn Infants: A Randomised Control Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Parents and Statistician are blinded

Primary Purpose: Prevention

Condition

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

Intervention

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

Study Arms

• 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.
  Intervention: Other: Tahneek
• No Intervention: CONTROL
  Infants at risk for transient neonatal hypoglycemia following standard-of-care.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2018): 324
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 22, 2019
• Actual Primary Completion Date: May 22, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 1 Hour (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Saudi Arabia

Administrative Information

• NCT Number: NCT03726697
• Other Study ID Numbers: KAIMRC
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Jubara Alallah, King Abdullah International Medical Research Center
• Original Responsible Party: Same as current
• Current Study Sponsor: King Abdullah International Medical Research Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jubara Alallah, MD; King Abdullah International Medical Research Center

• PRS Account: King Abdullah International Medical Research Center
• Verification Date: May 2019