Using a new surfactant to prevent lung disease in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I interventional study aims to determine the safest dose of recombinant surfactant protein D (rfhSP-D) for preterm infants born before 30 weeks gestation. The study will involve administering rfhSP-D via an endotracheal tube to assess its safety and effectiveness in preventing neonatal chronic lung disease. Up to 24 infants will be enrolled, with dose escalation based on the occurrence of dose limiting events. The study will also measure the concentration of the drug in lung secretions and serum to evaluate its impact.

Why it matters

Who can join: the full rules

Participant Inclusion Criteria:

1. Inborn infants born at between 23 weeks and 0 days and 29 weeks and 6 days gestation.
2. Infant must be intubated or planned to be intubated for respiratory distress at time of eligibility check, and this should be done within 12 hours from time of birth.
3. Receiving standard surfactant therapy
4. Clinically stable on mechanical ventilation. Stability is defined at the time of IMP instillation and is defined below.
5. Written informed consent from parents/guardians/person with legal responsibility

Definition of stability:

1. Blood gases within the normal range for preterm infants (pH\>7.20; paCO2 \<60mmHg)
2. Mean blood pressure with or without inotropic support at at least gestational age or above (mmHg)
3. No evidence of a pneumothorax
4. Clinical observations within acceptable range for an infant of that gestational age
5. No stability concerns from the attending neonatologist

Participant Exclusion Criteria:

1. Congenital anomalies i.e any major antenatal diagnosed congenital abnormalities such as congenital heart disease, suspected or known chromosomal abnormalities
2. Parents/legal guardians unable to give consent due to learning or other difficulties
3. Infants requiring only CPAP support without the need for surfactant replacement therapy, i.e. without endotracheal intubation
4. Infants born in very poor condition and judged too sick or unstable to be included (high risk of mortality) in an experimental first in human study, for example infants that are requiring maximal intensive care therapy and have findings such as a grade IV intraventricular haemorrhage that is likely to be life limiting.
5. Infants that are born out of the participating site.
6. Participation in any other interventional study (participation in an observational study is permissible).

Where it's running

• University College London Hospitals
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Howard Clark, MBBS — University College London Hospital
• Study coordinator: Trial Manager
• Email: cctu.response@ucl.ac.uk
• Phone: 020 3108 4255

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lung Ultrasound Score to predict BPD in very preterm babies

  This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.

  Recruiting at 4 sites Azienda USL Reggio Emilia - IRCCS · Modena and 3 other locations · NCT07633184

• Caffeine in pregnancy: how the mother and baby handle it during delivery

  This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT07570121

• IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier

  This trial will try intravenous immunoglobulin (IVIG) given over five days to see if it helps very preterm infants (≤28 weeks) who show early signs of bronchopulmonary dysplasia.

  Recruiting Phase 2 International Peace Maternity and Child Health Hospital · Shanghai · NCT07561125

• Surfactant delivery methods in preterm infants with RDS in Sweden

  This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07550218

• Lung ultrasound score to guide surfactant timing in preterm newborns

  This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.

  Recruiting Hackensack Meridian Health · Hackensack, New Jersey · NCT07442669

• Predicting which newborns in a lower-level NICU will need extended breathing support

  This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07344714

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.