Healthy, white and term Born infants and Children Born 38-42 weeks postconceptional

Healthy, white preterm Born infants and Children Born <37 weeks postconceptional Which comply with the international criteria (Jobe and Bancalari) of a diagnosis of bronchopulmonary dysplasia (BPD), or of chronic lung disease of the new-born (CLD)

White preterm Born infants and Children, including Twins Born <37 weeks postconceptional With fetal growth restriction (FGR), intrauterine growth restriction (IUGR) or preeclampsia (PE) With gestational Diabetes (GDM) With IVF or Amnion dysfunction

Nasal swabs, oropharyngeal swabs, nasal brush, sputum, cord blood, blood, urine

Healthy Volunteers

No intervention

University Children's Hospital

Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants

Longitudinal assessment of lung volume and ventilation inhomogeneity

Longitudinal assessment of ventilation inhomogeneity.

Longitudinal assessment of regional lung perfusion and ventilation

Longitudinal assessment of viral and bacterial colonization of the nasal swab

Respiratory virus and bacterial diagnostic

Respiratory viruses and Bacteria, changes of the microbial flora

Estimation of tobacco exposure during pregnancy.

Assessment of mononuclear cells, which regulate the innate and adaptive immunity.

Assessment of the history of atopy and allergy

Level of particulate matter <10um, Nitrogen dioxide, ozone and particulate matter <2.5um.

Longitudinal assessment of viral and bacterial colonization.

Longitudinal assessment of the sputum neutrophils.

University Hospital Inselspital, Berne

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Single Arm: Varied Albuterol Dose Response

Sex: Female, Male

birthweight

gestational age at birth

respiratory support at study entry, CPAP

respiratory support at study entry, mechanical ventilation

history of any mechanical ventilation

received surfactant

received antenatal corticosteroids

ever received albuterol prior to study entry

received diuretics prior to study entry

reason for preterm delivery: preterm labor

maternal age, years (mean)

maternal BMI (mean, range)

maternal diabetes mellitus (pregestational or gestational)

family history of asthma

maternal smoking during pregnancy

second hand smoke exposure during pregnancy

The primary outcome is the percentage of subjects who show a positive response to each dose of albuterol. A positive response is defined as a greater than or equal to 10% decrease in respiratory resistance (Rrs). The change in RRs was measured at baseline and again after each dose of albuterol. All measurements were taken within a 7 day time frame for each subject such that each subject would have up to 3 results measured during a 7 day period, if he/she were able to complete three sets of PFTs according to study protocol. The change in Rrs was calculated by subtracting the baseline Rrs from the post-albuterol Rrs.

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Change in Respiratory Resistance

Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Number of Participants With Positive Response at Different Albuterol Doses

birth weight in grams of each subject was recorded at time of enrollment

Birth Weight of Albuterol Responders vs Non Responders

Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response

Gestational Age at Birth

Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia).

Etiology of Preterm Delivery

Family history was obtained from verbal history by subject's mother at time of enrollment in study. A positive family history was noted if a first degree relative of the subject (infant) had a diagnosis of asthma.

Family History of Asthma and Likelihood to Respond to Albuterol

Maternal BMI will be obtained from her medial record, and she will be asked about weight gain during pregnancy at time of enrollment. Results will be compared for infants born to women with a normal BMI vs. those with obese BMI (>30).

Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol

Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants

Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol

First Dose (180 mcg Albuterol)

Second Dose (270 mcg Albuterol)

Third Dose (360 mcg Albuterol)

Cindy McEvoy, MD

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. Resistance and compliance will be measured using the single breath occlusion technique.
Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Bronchopulmonary Dysplasia

Very Low Birth Weight

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to 33w6d. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

bronchopulmonary dysplasia/nikotin

Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants

Preterm Infant Inhaled Albuterol Dosing

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