60% oxygen group for Premature Birth

1
Effectiveness
1
Safety
Royal Alexandra Hospital, Edmonton, Canada
Premature Birth+6 More
60% oxygen group - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Premature Birth

Study Summary

This study is evaluating whether resuscitating babies with a lower oxygen concentration is better than resuscitating them with a higher concentration.

See full description

Eligible Conditions

  • Premature Birth
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome
  • Birth Weight
  • Infants, Premature
  • Neurodevelopmental Outcomes
  • Respiratory Distress Syndrome In Premature Infants

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 60% oxygen group will improve 3 primary outcomes and 3 secondary outcomes in patients with Premature Birth. Measurement will happen over the course of first 15 minutes after birth.

18-24 months of age
Blindness
Healing loss
Neurodevelopmental outcome at 18-24 months
Month 3
Death in the Neonatal Intensive Care Unit
Hour 3
Death in the delivery room
first 15 minutes after birth
Number of intubation in the delivery room

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

30% group
60% group

This trial requires 1200 total participants across 2 different treatment groups

This trial involves 2 different treatments. 60% Oxygen Group is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

60% group
Drug
Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age. Intervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.
30% group
Drug
Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age. Intervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18-24 months of age
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18-24 months of age for reporting.

Closest Location

Royal Alexandra Hospital - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Infants born at 23 0/7 weeks to 28 6/7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is 60% oxygen group safe for people?

Add answer

Compared with ambient oxygen, moderate levels of oxygen by face mask do not increase the risk of adverse obstetric or perinatal outcomes in nulliparous and parous women with premature rupture of membranes.

Unverified Answer

How many people get premature birth a year in the United States?

Add answer

Only a small number of women are at risk for a preterm birth. Most women with a preterm birth do not have preterm births before 20 weeks. Most preterm births result from the health risks associated with being older or sicker than average. Women of all ages, races, ages, and socioeconomic statuses and geographic areas have an increased risk for preterm deliveries. Copyright © 2016 John Wiley & Sons, Ltd.

Unverified Answer

What are common treatments for premature birth?

Add answer

What are the most common treatments to prevent cerebral palsy in premature birth? The two common treatment options to prevent neurological problems can be traced back to the neonatal period. Neonatal intensive care unit (NICU) is an important and key treatment option, but the effectiveness of the NICU has been questioned.

Unverified Answer

What is premature birth?

Add answer

Very premature babies are at risk of serious problems including bronchopulmonary dysplasia, cerebral palsy, retinopathy of prematurity, impaired hearing, intellectual disability, and social or behavioral problems.\n\n- www.schizophrenia.org"

"Sawadini\n\nSawadini is an extinct tribe of armored carnivoran mammals belonging to the subfamily Soricomorpha. They are known from fossils found in the Oligocene of the Baltic and Uralic regions.

Unverified Answer

What are the signs of premature birth?

Add answer

The signs of premature birth are premature skin bruising (often associated with capillary dilation, as is frequently found in fetal malnutrition), decreased ability of the lungs to do work, and low blood oxygen levels. The signs in the mother may include vaginal bleeding, and an irregular or very fast rate of labour in early pregnancy. There is also increased chance of rupture of membranes. In the baby, the signs of premature birth may include lethargy and lack of interest in the presence of the mother.\n

Unverified Answer

Can premature birth be cured?

Add answer

It appears that there is no "cure" and that many long-term problems have been cured. These issues can be a part of what causes psychological distress in the first four to five years after premature birth, and must be looked at as part of a comprehensive assessment to fully understand the problems that occur. However, no conclusions can be drawn concerning the treatment of those whose psychological problems have not been properly addressed. It is advised that patients be referred for appropriate treatment where this is indicated. It is the responsibility of the paediatrician to ensure that the parents are fully informed of the potential problems and issues and to ensure that the parents have had the opportunity to express their feelings and concerns.

Unverified Answer

What causes premature birth?

Add answer

Premature birth is caused as a result of a combination of factors, mostly maternal, that cause early or incomplete maturation of the fetal brain. These factors include: genetics, intra-uterine insults, and infections during pregnancy. For example, the baby develops in a non-ideal environment due to a mother who is not sufficiently sensitive and able to give her child the proper amounts of stimulation and care during early development.\n

Unverified Answer

What is the average age someone gets premature birth?

Add answer

[The average age of women who gave birth to preterm babies (premature birth) at home in the last two years was 26.5 years. (Source: 1, US Department of Health and Human Services (HHS), 2006 Annual Birth Survey Report)] In other words, preterm birth rates are relatively steady when they are adjusted for birthweight and gestational age at delivery. That being said, there were two types of preterm births (the first is premature preterm birth, the second is very preterm preterm birth). Premature births are [often associated with problems for the baby and the mother and a risk for long-term health consequences] (US Department of Health and Human Services (HHS), 2016 annual report).

Unverified Answer

Have there been other clinical trials involving 60% oxygen group?

Add answer

There was no significant difference in neonatal morbidity between the 60% O2 group and the room air, room air supplemented with 40% oxygen group. The percentage of cases meeting the study objective was 92.9. These data suggest that 60% is an effective percentage for neonatal hypoxia, and are similar to those from other clinical trials.

Unverified Answer

Does premature birth run in families?

Add answer

Premature birth is not statistically significantly related to premature birth in siblings. Premature birth was associated with lower education level and being male. Since the siblings of premature children were still asymptomatic but had a higher chance of having premature births themselves, we postulate that premature birth runs in families.

Unverified Answer

How does 60% oxygen group work?

Add answer

Because preterm infants who breathed 60% oxygen had higher mean arterial pressures and mean total blood flow to the cerebral hemisphere with respect to the control group, cerebral hemodynamics of premature infants on 60% oxygen at two weeks of age may be less dependent on systemic hemodynamics than they were in term infants.

Unverified Answer

Is 60% oxygen group typically used in combination with any other treatments?

Add answer

60% O2 is used in combination with most other therapies; it can be used alone in certain circumstances. Ophthalmic medications did not have a clear benefit when given in combination with the 60% O2. Therefore, treatment with a combination of 60% O2 and medications should be reconsidered on a case-by-case basis. However, the use of treatment in conjunction with oxygen should be discouraged. Additional randomized clinical trials are needed to confirm these results.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Premature Birth by sharing your contact details with the study coordinator.