Introduction

Surf on is a large multicentre randomised controlled trial of different treatment approaches for surfactant treatment  in babies born between 34+0 and 38+6 week’s gestation. 

The Royal infirmary of Edinburgh is a recruiting centre. 

The Local Principal Investigator is Professor Ben Stenson 

The Study Nurse is Sally Yip 

Ben and Sally will always be happy to discuss the study with anyone who is interested in learning more and to provide support if required. We need your help in identifying and recruiting eligible babies so that they can be entered into the study. 

Full details of the study are available on the National Perinatal Epidemiology Unit website  and Protocol 

Aim

The aim of the study is to determine whether more mature infants with respiratory distress who require supplemental oxygen and who have been started on non-invasive respiratory support benefit from early intervention with surfactant treatment or whether their outcomes are better if surfactant treatment is only given to babies who develop more significant respiratory difficulty. There is widespread variation in practice in these babies because they have not been studied before. 

If you would like to view a brief video podcast about the study it can be viewed below

There are helpful laminated guidance sheets about every aspect of study process in the study information box at the staff base. If you take these out please remember to return them. 

1. Born at 34⁺⁰–38⁺⁶ weeks of gestation 

2. ≤ 24 hours old 

3. Respiratory distress defined as; 

• • FiO2 ≥ 0.3 and < 0.45 needed to maintain SaO2 ≥ 92%, or 
  • Clinically significant work of breathing, regardless of FiO2 

4. Clinical decision to provide non-invasive respiratory support 

5. Written parental informed consent 

1. Major structural or chromosomal abnormality
2. No realistic prospect of survival
3. Prior intubation and/or surfactant administration
4. Known or suspected hypoxic ischaemic encephalopathy
5. Congenital abnormality of the upper or lower respiratory tract
6. Known or suspected neuromuscular disorder 

If an eligible baby is identified then the parents should be approached for consent for their baby to be included in the study (has to be a staff member who has been allocated this responsibility on the study delegation log). 

Parent information leaflets and consent forms are available in the study box at the staff base. We hope that the parents will agree to their baby being included in the study and to complete some short questionnaires about their involvement at the time of enrolment and discharge. Separate consent is given for putting the baby in the trial and for the parent to complete the questionnaires. 

When consent has been obtained the baby will be randomised to :-

Early surfactant therapy 

Surfactant administration should occur as soon as possible after the infant has been randomised using the preferred administration method of the treating clinician 

or 

Expectant management 

The baby should stay on non-invasive support.  The baby can receive surfactant later if the treating clinician thinks that it is needed and the baby has 

sustained (≥ 30 minutes) requirement for FiO2 ≥ 0.45 to maintain oxygen saturations (SaO2) ≥ 92% 

In either study group, if intubation is required for another reason, surfactant may be given if the attending clinician deems this necessary 

Randomisation 

To randomise a baby you must have been allocated this responsibility on the Trial Delegation Log. 

Please ensure that the maternal trial entry questionnaire has been completed if consent was obtained for this (there should be one for to each baby if multiples are being entered into the study). 

Go to the Trial Randomisation site 

Select Royal Infirmary of Edinburgh on the drop down list. 

Enter your Username: Edinburgh 

and Password : Skier-334 

Click the login button. 

Click  Enter Infant 

Complete the eligibility questions 

You will need to know the expected date of delivery, date of birth, time of birth, sex, current FiO2 

Click complete when the form is filled in. 

The system will generate the randomisation and produce a randomisation number. Please enter this number on the consent form and the mother’s questionnaire. 

Please print the randomisation information and keep it with the other documents for the study team.  You can put it in the documentation box at the staff base. 

Please click the contact details button and enter contact details for the baby and mother. 

Once you have completed the randomisation and contact details, please complete the electronic trial entry form on the trial clinical database Open Clinica

The baby should get a cot card 

A paper respiratory support log must to be given to the nursing staff. This records the respiratory support required by the baby and must be completed by the nurse once per 4 hours. One log is enough for up to 7 days. If the baby is breathing air off all support for 24 hours the log can be stopped. If the baby needs support for more than 7 days a second log should be started. 

Other data entry forms will be completed by Ben and Sally. 

If the baby is to be transferred to another unit please inform Ben or Sally. If baby is being discharged please inform Ben or Sally. 

There are discharge questionnaires to give to the parent to complete at the time of discharge (one per baby if multiples enrolled). 

If there is any concern about a possible adverse event related to the study please contact Ben promptly because these must be reported within 24 hours.