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Trial registered on ANZCTR


Registration number
ACTRN12607000132448
Ethics application status
Approved
Date submitted
15/02/2007
Date registered
16/02/2007
Date last updated
16/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of Maternity Home routines on baby’s temperature adaptation, breastfeeding outcome, maternal-infant interaction, infant’s development and health.
Scientific title
Influence of Maternity Home routines, including skin-to-skin contact vs early separation, rooming-in vs staying in the nursery, swaddling vs baby clothes, for healthy newborn infants and healthy new mothers on baby's temperature adaptation, breastfeeding outcome, maternal-infant interaction, infant's development and health.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal care 1624 0
Condition category
Condition code
Reproductive Health and Childbirth 1732 1732 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mother-infant pairs were randomised into four groups according to an experimental two-factor design taking into account infant location and apparel. Group I infants were placed skin-to-skin on their mother’s chest in the delivery ward. Infants were later kept roomed-in in the maternity ward. Group II infants were dressed and placed in their mother's arms. Infants were later kept roomed-in in the maternity ward. Group III infants were kept in a cot in the delivery and maternity ward nurseries with no rooming-in. Group IV infants were kept in a cot in a delivery ward nursery and later roomed-in in the maternity ward. Each group comprised two subgroups with infants either swaddled or kept in clothes. The duration of stay in the delivery ward was 2 first hours after birth; the duration of stay in the maternity ward lasted till discharge at day 5 after birth.
Intervention code [1] 1600 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2405 0
1) Mean maternal and infant temperature
Timepoint [1] 2405 0
During 30-120 minutes after birth, measured each 15 minutes
Primary outcome [2] 2406 0
2) Mean amount of breast-milk digested by infants
Timepoint [2] 2406 0
During day 4 postpartum (from 72 to 96 pospartal hours)
Primary outcome [3] 2407 0
3) Parent-Child Early Relational Assessment (PCERA) composite variables
Timepoint [3] 2407 0
Measured at 1 year to evaluate maternal-infant interaction.
Secondary outcome [1] 4183 0
1) Length of exclusive breastfeeding during the first year of life
Timepoint [1] 4183 0
Assessed monthly
Secondary outcome [2] 4184 0
2) Length of infant's swaddling during the first year of life
Timepoint [2] 4184 0
Assessed monthly
Secondary outcome [3] 4185 0
3) Infant's physical and neuro-psychological development
Timepoint [3] 4185 0
At 1, 2, 3, 4, 6, 9 and 12 months
Secondary outcome [4] 4186 0
4) Infant's health during the first year
Timepoint [4] 4186 0
Assessed at 1, 2, 3, 4, 6, 9 and 12 months.

Eligibility
Key inclusion criteria
Healthy mothers with full-term, singleton, uncomplicated pregnancies and non-instrumental deliveries, with intention to breastfeed their babies; healthy newborn infants (without congenital maformations, not "small for date", with Apgar score not less than 8 at 5 minuts after birth).
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Oxytocin infusion during labour; analgesia like epidural, paracervical or pudendal block.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes were used for allocation concealment of mother-infant dyads.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software. Randomisation was blocked for time and parity.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 486 0
Sweden
State/province [1] 486 0

Funding & Sponsors
Funding source category [1] 1881 0
Charities/Societies/Foundations
Name [1] 1881 0
Royal Swedish Academy of Science
Address [1] 1881 0
Country [1] 1881 0
Sweden
Funding source category [2] 1882 0
Government body
Name [2] 1882 0
Swedish International Development Cooperation Agency
Address [2] 1882 0
Country [2] 1882 0
Sweden
Primary sponsor type
University
Name
Karolinska Institutet, Department of Woman and Child Health, Division of Reproductive and Perinatal Health Care
Address
Country
Sweden
Secondary sponsor category [1] 1697 0
Hospital
Name [1] 1697 0
St-Petersburg Pediatric Medical Academy, Department of Hospital Pediatrics
Address [1] 1697 0
Country [1] 1697 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3506 0
Karolinska Institutet
Ethics committee address [1] 3506 0
Ethics committee country [1] 3506 0
Sweden
Date submitted for ethics approval [1] 3506 0
Approval date [1] 3506 0
21/03/1994
Ethics approval number [1] 3506 0
Nr 94:55

Summary
Brief summary
Maternity Home practices still existing in some countries (separation of newborn infants from their mothers immediately after birth, tight swaddling, keeping babies in the nursery without rooming-in with their mothers, scheduled breastfeeding, formula supplementation) might hinder temperature adaptation even in healthy babies, can influence early breastfeeding performance as well as duration of breastfeeding in a long run. Moreover, infant's development, health and maternal-infant interaction and attachment could be also affected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27534 0
Address 27534 0
Country 27534 0
Phone 27534 0
Fax 27534 0
Email 27534 0
Contact person for public queries
Name 10789 0
Associate Professor Ann-Marie Widström
Address 10789 0
Department of Woman and Child Health
Division of Reproductive and Perinatal Health Care
Karolinska Institutet
Retzius väg 13 A
17177 Stockholm
Country 10789 0
Sweden
Phone 10789 0
+46 08 52482413
Fax 10789 0
+46 08 524 824 00
Email 10789 0
ann-marie.widstrom@ki.se
Contact person for scientific queries
Name 1717 0
Associate Professor Ann-Marie Widström
Address 1717 0
Department of Woman and Child Health
Division of Reproductive and Perinatal Health Care
Karolinska Institutet
Retzius väg 13 A
17177 Stockholm
Country 1717 0
Sweden
Phone 1717 0
+46 08 52482413
Fax 1717 0
+46 08 524 824 00
Email 1717 0
ann-marie.widstrom@ki.se

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary