Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
15/01/1995
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
176
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
Country [1] 1881 0
Sweden
Funding source category [2] 1882 0
Government body
Name [2] 1882 0
Swedish International Development Cooperation Agency
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.