Measuring and Reducing Excessive Infant Crying (UTHealth THB)
Measuring and Reducing Excessive Infant Crying: A Randomized Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77030
- University of Texas Health Science Center at Houston
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Exclusion Criteria:
- cannot have a condition which would reasonably impact alertness or behavior
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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Aktiv komparator: AAP Education
Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
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Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean night-time crying
Tidsram: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Objectively recording night-time duration of excessive crying
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Mean sleep duration
Tidsram: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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objectively measuring infant sleep duration
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maternal Depression, Anxiety and Somatization
Tidsram: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Using the BSI-18 at study enrollment and conclusion.
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At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Salivary Biomarkers
Tidsram: At Study Entry and at 2 weeks after enrollment
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We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
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At Study Entry and at 2 weeks after enrollment
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Samarbetspartners och utredare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSC-MS-10-0392
- K23HD065872 (U.S.S. NIH-anslag/kontrakt)
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