Bronchopulmonary DysplasiaNCT00005294
Developmental Sequelae of Severe Chronic Lung Disorders
An observational study of Bronchopulmonary Dysplasia and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Bronchopulmonary Dysplasia, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1989to Jun 1995
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.
Read the detailed description
BACKGROUND:
Bronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. Although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research.
DESIGN NARRATIVE:
In this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. Demographic, birth, and medical data were collected at baseline through chart review. Standardized questionnaires measuring parental stress and family support were administered to the parents. Infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children's physical growth, medical status, cognitive, language and behavioral development. Feeding behaviors were assessed through standardized observation and interview at each visit. Data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Bronchopulmonary Dysplasia, Lung Diseases
- Medical subject headings
- Bronchopulmonary Dysplasia, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1989
- Study completionJun 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005294
- Sponsor's protocol ID
- 2017
- Other IDs
- R01HL038193
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. doi: 10.1542/peds.100.6.987.
PubMed 9374570Singer L, Martin RJ, Hawkins SW, Benson-Szekely LJ, Yamashita TS, Carlo WA. Oxygen desaturation complicates feeding in infants with bronchopulmonary dysplasia after discharge. Pediatrics. 1992 Sep;90(3):380-4.
PubMed 1518692Singer L, Farkas K, Kliegman R. Childhood medical and behavioral consequences of maternal cocaine use. J Pediatr Psychol. 1992 Aug;17(4):389-406. doi: 10.1093/jpepsy/17.4.389.
PubMed 1382125Singer LT, Ambuel B, Wade S, Jaffe AC. Cognitive-behavioral treatment of health-impairing food phobias in children. J Am Acad Child Adolesc Psychiatry. 1992 Sep;31(5):847-52. doi: 10.1097/00004583-199209000-00011.
PubMed 1400116Singer LT, Hill BP, Orlowski JP, Doershuk CF. Medical and social factors as predictors of outcome in infant tracheostomy. Pediatr Pulmonol. 1991;11(3):243-8. doi: 10.1002/ppul.1950110310.
PubMed 1722034Singer LT, Garber R, Kliegman R. Neurobehavioral sequelae of fetal cocaine exposure. J Pediatr. 1991 Oct;119(4):667-72. doi: 10.1016/s0022-3476(05)82426-6.
PubMed 1919905Singer LT, Nofer JA, Benson-Szekely LJ, Brooks LJ. Behavioral assessment and management of food refusal in children with cystic fibrosis. J Dev Behav Pediatr. 1991 Apr;12(2):115-20.
PubMed 2045484Singer LT, Yamashita TS, Hawkins S, Cairns D, Baley J, Kliegman R. Increased incidence of intraventricular hemorrhage and developmental delay in cocaine-exposed, very low birth weight infants. J Pediatr. 1994 May;124(5 Pt 1):765-71. doi: 10.1016/s0022-3476(05)81372-1.
PubMed 7513757Singer L, Arendt R, Minnes S. Neurodevelopmental effects of cocaine. Clin Perinatol. 1993 Mar;20(1):245-62.
PubMed 8458168Singer L, Arendt R, Song LY, Warshawsky E, Kliegman R. Direct and indirect interactions of cocaine with childbirth outcomes. Arch Pediatr Adolesc Med. 1994 Sep;148(9):959-64. doi: 10.1001/archpedi.1994.02170090073014.
PubMed 8075743Singer LT, Davillier M, Preuss L, Szekely L, Hawkins S, Yamashita T, Baley J. Feeding interactions in infants with very low birth weight and bronchopulmonary dysplasia. J Dev Behav Pediatr. 1996 Apr;17(2):69-76.
PubMed 8727839
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Sequelae of Severe Chronic Lung Disorders
- ClinicalTrials.gov ID
- NCT00005294
- Acronym / sponsor ID
- 2017
- Conditions
- Bronchopulmonary Dysplasia, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1989
- Study completion
- Jun 1995 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.
Detailed description
BACKGROUND:
Bronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. Although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research.
DESIGN NARRATIVE:
In this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. Demographic, birth, and medical data were collected at baseline through chart review. Standardized questionnaires measuring parental stress and family support were administered to the parents. Infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children's physical growth, medical status, cognitive, language and behavioral development. Feeding behaviors were assessed through standardized observation and interview at each visit. Data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 9374570Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. doi: 10.1542/peds.100.6.987.
- Background: PubMed 1518692Singer L, Martin RJ, Hawkins SW, Benson-Szekely LJ, Yamashita TS, Carlo WA. Oxygen desaturation complicates feeding in infants with bronchopulmonary dysplasia after discharge. Pediatrics. 1992 Sep;90(3):380-4.
- Background: PubMed 1382125Singer L, Farkas K, Kliegman R. Childhood medical and behavioral consequences of maternal cocaine use. J Pediatr Psychol. 1992 Aug;17(4):389-406. doi: 10.1093/jpepsy/17.4.389.
- Background: PubMed 1400116Singer LT, Ambuel B, Wade S, Jaffe AC. Cognitive-behavioral treatment of health-impairing food phobias in children. J Am Acad Child Adolesc Psychiatry. 1992 Sep;31(5):847-52. doi: 10.1097/00004583-199209000-00011.
- Background: PubMed 1722034Singer LT, Hill BP, Orlowski JP, Doershuk CF. Medical and social factors as predictors of outcome in infant tracheostomy. Pediatr Pulmonol. 1991;11(3):243-8. doi: 10.1002/ppul.1950110310.
- Background: PubMed 1919905Singer LT, Garber R, Kliegman R. Neurobehavioral sequelae of fetal cocaine exposure. J Pediatr. 1991 Oct;119(4):667-72. doi: 10.1016/s0022-3476(05)82426-6.
- Background: PubMed 2045484Singer LT, Nofer JA, Benson-Szekely LJ, Brooks LJ. Behavioral assessment and management of food refusal in children with cystic fibrosis. J Dev Behav Pediatr. 1991 Apr;12(2):115-20.
- Background: PubMed 7513757Singer LT, Yamashita TS, Hawkins S, Cairns D, Baley J, Kliegman R. Increased incidence of intraventricular hemorrhage and developmental delay in cocaine-exposed, very low birth weight infants. J Pediatr. 1994 May;124(5 Pt 1):765-71. doi: 10.1016/s0022-3476(05)81372-1.
- Background: PubMed 8458168Singer L, Arendt R, Minnes S. Neurodevelopmental effects of cocaine. Clin Perinatol. 1993 Mar;20(1):245-62.
- Background: PubMed 8075743Singer L, Arendt R, Song LY, Warshawsky E, Kliegman R. Direct and indirect interactions of cocaine with childbirth outcomes. Arch Pediatr Adolesc Med. 1994 Sep;148(9):959-64. doi: 10.1001/archpedi.1994.02170090073014.
- Background: PubMed 8727839Singer LT, Davillier M, Preuss L, Szekely L, Hawkins S, Yamashita T, Baley J. Feeding interactions in infants with very low birth weight and bronchopulmonary dysplasia. J Dev Behav Pediatr. 1996 Apr;17(2):69-76.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005294, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.