IRCT | Investigation of the effect of head coverage on the prevention of hypocalcemia and hypo magnesium caused by photo-therapy in premature infants with jaundice.

Protocol summary

Study aim: Evaluation of the effect of head coverage on the prevention of hypocalcemia and hypomagnesemia caused by photo-therapy in premature infants with jaundice.
Design: The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized
Settings and conduct: The aim of this study was to investigate the effect of head covering on prevention of hypocalcemia and hypomagnesemia resulting from phototherapy on jaundice infants admitted to the Shahidan Mobini Hospital in Sabzevar. In this study, participants were unaware of how infants were grouped. infants are randomly assigned to the intervention group (cover the head with a hat) and the control (without hat). The response to treatment will be evaluated by checking before and 48 hours after phototherapy the total serum calcium, magnesium, and bilirubin levels in the two groups.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Gestational age 30-35 weeks; Perinatal asphyxia; lack of congenital anomaly; lack of neonatal sepsis and IUR; lack of receiving sodium bicarbonate and exchange of blood; non-interference head covering during phototherapy; lack of mother's catch to gestational diabetes and hyperparathyroidism. Exclusion criteria: Neonatal sepsis, Perinatal asphyxia, Congenital anomalies, Receiving sodium bicarbonate and exchange blood, Mother's catch to gestational diabetes and hyperparathyroidism, IUR.
Intervention groups: Intervention group: In this group, the patient's head is covered with a hat, using a white cotton hat. Before and 48 hours after phototherapy, total serum calcium, magnesium, and bilirubin levels are measured. Control group: In this group, no specific work is done for patients, and total serum calcium, magnesium, and bilirubin levels are measured before and 48 hours after phototherapy.
Main outcome variables: Determination of the mean serum level of calcium and magnesium

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20181006041252N1

Registration date: 2018-10-26, 1397/08/04

Registration timing: registered_while_recruiting

Last update: 2018-10-26, 1397/08/04

Update count: 0
Registration date: 2018-10-26, 1397/08/04

Registrant information: Name

Mohammad Sahebkar

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 51 4401 8337

Email address

sahebkarm@medsab.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-10-15, 1397/07/23
Expected recruitment end date: 2019-01-13, 1397/10/23
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigation of the effect of head coverage on the prevention of hypocalcemia and hypo magnesium caused by photo-therapy in premature infants with jaundice.

Public title: The effect of head coverage on the prevention of hypocalcemia and hypomagnesia.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Gestational age 30-35 weeks Lack of congenital anomaly since birth Lack of receiving sodium bicarbonate and exchange of blood Lack of mother's catch to the gestational diabetes and hyperparathyroidism Lack of using anticonvulsants by mother during pregnancy Non-interference head covering during phototherapy Perinatal asphyxia (Apgar score in the minute 5 between 0 to 3, Ph and bicarbonate of the umbilical cord less than 7 and 12 respectively).

Exclusion criteria:

Neonatal sepsis Perinatal asphyxia Congenital anomalies since birth Receiving sodium bicarbonate and exchange blood Mother's catch to the gestational diabetes and hyperparathyroidism Mother's use of anticonvulsants during pregnancy Intrauterine gestational retardation Interventions cover the head during phototherapy
Age: From 8 months old to 9 months old
Gender: Both

Phase

3

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Block randomization based on permutation. Accordingly, 30 blocks were allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, Group A is covered with a hat and group B does not get any special action.

Blinding (investigator's opinion)

Double blinded

Blinding description

Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The outcome evaluator and the practitioner is unaware of the groups.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Sabzevar University of Medical Sciences

Street address

Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city

City

Sabzevar

Province

Razavi Khorasan

Postal code

9617913114
Approval date: 2018-09-18, 1397/06/27
Ethics committee reference number: IR.MEDSAB.REC.1396.035

Health conditions studied

1

Description of health condition studied: Jaundice
ICD-10 code: P59.9
ICD-10 code description: Neonatal jaundice, unspecified

Primary outcomes

1

Description: Hypocalcemia: A deficiency and low serum calcium concentration in the blood, usually less than 1.2 mmol / L or 9 mg / dL.
Timepoint: At the beginning of the study (before the intervention) and 48 hours after phototherapy
Method of measurement: Flame photometry device

2

Description: Hypo-magnesium: A deficiency and low serum concentration of magnesium in the blood, which is usually less than 1.5 mg per cent.
Timepoint: At the beginning of the study (before the intervention) and 48 hours after phototherapy
Method of measurement: Flame photometry device

Secondary outcomes

1

Description: Neonatal Jaundice or Hyperbilirubinemia (i.e., over 2 mg / dL)
Timepoint: At the beginning of the study (before the intervention) and 48 hours after phototherapy
Method of measurement: Flame photometry device

Intervention groups

1

Description: Intervention group: In this group, the patient's head is covered with a hat, using a white cotton hat. Before and 48 hours after photo therapy, total serum calcium, magnesium, and bilirubin levels are measured.
Category: Treatment - Devices

2

Description: Control group: In this group, no specific work is done for patients, and total serum calcium, magnesium, and bilirubin levels are measured before and 48 hours after photo therapy.
Category: Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Heshmatiyeh hospital

Full name of responsible person

Samaneh

Street address

Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town

City

Sabzevar

Province

Razavi Khorasan

Postal code

9613873136

Phone

+98 51 4401 1014

Email

Dr_samaneh2000@yahoo.com

1

Sponsor: Name of organization / entity

Sabzevar University of Medical Sciences

Full name of responsible person

Dr. Fereshte Ghorat

Street address

Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town

City

Sabzevar

Province

Razavi Khorasan

Postal code

9617913114

Phone

+98 51 4401 8319

Email

Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Sabzevar University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Sabzevar University of Medical Sciences

Full name of responsible person

Dr. Nasrin Hashemian

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

General Practitioner

Street address

Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town

City

Sabzevar

Province

Razavi Khorasan

Postal code

9617913114

Phone

+98 51 4401 1604

Email

Hashemianmehr@live.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Sabzevar University of Medical Sciences

Full name of responsible person

Dr. Nasrin Hashemian

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

General Practitioner

Street address

Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town

City

Sabzevar

Province

Razavi Khorasan

Postal code

9671965751

Phone

+98 51 4401 1604

Email

Hashemianmehr@live.com

Person responsible for updating data

Contact: Name of organization / entity

Sabzevar University of Medical Sciences

Full name of responsible person

Samaneh Pajoheshgar

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

General Practitioner

Street address

Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town

City

Sabzevar

Province

Razavi Khorasan

Postal code

9617913114

Phone

+98 51 3760 3594

Email

Dr_Samaneh2000@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Investigation of the effect of head coverage on the prevention of hypocalcemia and hypo magnesium caused by photo-therapy in premature infants with jaundice.