Effect of Head Covering with a Hat on Serum Calcium and QTc Interval in Term &Preterm Icteric Newborns Under Phototherapy admitted in Rasht 17 Shahrivar hospital: A Randomized Clinical Trial

The purpose of this study is to investigate the prevalence of phototherapy-induced hypocalcemia in term and preterm icteric infants and to investigate the prophylactic effect of wearing a hat on serum calcium levels and QTC interval.

A paralleled controlled randomized clinical trial, without blinding, phase 3 on 86 patients. Four random blocks method is used for randomization.

A randomized clinical trial will be done at 17 Shahrivar Hospital, Rasht, after obtaining informed consent from parents. It is a non-blinded study.

Infants with jaundice will be included in the study. exclusion criteria were: Bilirubin close to blood exchange limit Sepsis respiratory distress Anomaly and dysmorphism of the face Congenital heart problems Babies of diabetic mothers History of parathyroid problems in the mother Taking anticonvulsant drugs in the mother Birth asphyxia or low Apgar Infants with intrauterine mental retardation Babies under intravenous nutrition Hypocalcemia test on arrival

For icteric babies under phototherapy in the intervention group, head covering with a dark hat that completely covers the occiput, ears and back of the neck is also used under the phototherapy device in addition to diapers and blindfolds. The color, material and shape of the hat will be the same in all babies of the intervention group. Blood calcium check and ECG are performed at 0 and 48 hours after phototherapy. For 43 icteric infants in the control group, no hat is put on to cover them, and they only undergo phototherapy with routine blindfold and diaper coverage.

Primary outcome: investigating the frequency of hypocalcemia in two groups after 48 hours of phototherapy. Secondary outcome: comparison of QTC changes in two groups after 48 hours of phototherapy

The randomization process will be carried out under the supervision of the project manager and by her and with the direct supervision of the statistician and the supervisor. Children with admission criteria based on daily visits to the children's clinic are included in the study through consecutive sampling. For randomization, the quadruple random block method is used. According to the sample size of 86 and equal to 43 people in each group, 16 blocks of 4 complete blocks and one double block will be selected. The random allocation of samples is based on the sequence list that is done through the random block allocation software. Children who meet the entry criteria are randomly assigned to Group A (cover the head with hat) and Group B (without hat) based on the list.

Ethical considerations